• Available to treat adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement  

  .. PEMAZYRE^® (pemigatinib) is available via a co-pay access program in Australia

Melbourne, Australia, 15 September 2022: A NEW targeted therapy to treat a rare bile duct cancer called cholangiocarcinoma has been approved for use in Australia.

PEMAZYRE^® (pemigatinib) has been provisionally approved by the Therapeutic Goods Administration (TGA) “for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR).  Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).” ¹

This means it will be available to Australian patients with cholangiocarcinoma who have been tested for an abnormal gene change in their tumour called an FGFR2 fusion or rearrangement – a defect that can drive cancer growth.

This defect is estimated to be present in around 15% of patients diagnosed with cholangiocarcinoma.²

Australian oncologist Dr David Goldstein said the approval of PEMAZYRE was “a significant step forward” for Australian patients who are diagnosed with this rare and aggressive cancer.

He commented: “This TGA approval of a targeted therapy heralds an era of precision medicine in this rare cancer.

“The study underpinning this approval, FIGHT 202, saw clinical outcomes you would not expect from previous experience after initial treatment ceases to be effective.

“This is one of only a few second-line therapies to offer serious real benefits to patients and will be very focused upon the right tumour type.

“Up until now, we have had some chemotherapies that were effective, but only in a minority of patients.

“This TGA approval is a positive first step. Subsequent reimbursement via the Pharmaceutical Benefits Scheme is really the only way forward to translate this scientific knowledge of targeting a specific tumour type into everyday clinical practice.”

PEMAZYRE, developed by Incyte (NASDAQ:INCY) and partnered with independent pharmaceutical company Specialised Therapeutics (ST) for commercialisation in Australia, New Zealand and Singapore, belongs to a class of drugs called kinase inhibitors and works by blocking the abnormal FGFR2 protein in bile duct tumour cells and preventing cell growth.

The TGA approval follows PEMAZYRE’s approval in the United States, Europe, Great Britain, Canada and Japan.

While PEMAZYRE is not yet reimbursed in Australia, it is currently being made available to eligible patients via a co-pay access program.

ST CEO Carlo Montagner said PEMAZYRE was a “wonderful inclusion” to the company’s portfolio of rare cancer therapies and was synergistic with its mission of providing therapies to patient populations where there is a high unmet medical need.

He said: “We look forward to providing this new highly-targeted treatment to eligible patients with cholangiocarcinoma who have limited therapy options.”

PEMAZYRE’s approval is based on a clinical trial known as the FIGHT-202 study – a Phase 2 investigation evaluating the safety and efficacy of PEMZYRE in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. ²

In the primary analysis of 108 patients enrolled in the trial, treatment with PEMAZYRE resulted in an objective response rate of 37% with 3.7% of patients having a confirmed complete response and 33.3% having a confirmed partial response. The disease control rate was 82.2%.¹

The safety analysis, including 147 patients, demonstrated that PEMAZYRE was generally well tolerated.

The most common adverse reactions were hyperphosphataemia: includes hyperphosphataemia and increased blood phosphorous (60.5%), alopecia (49.7%), diarrhoea (46.9%), nail toxicity (44.9%), fatigue (43.5%), nausea (41.5%), dysgeusia (40.8%), stomatitis (37.4%), constipation (36.7%), dry mouth (34.0%), dry eye (27.9%), arthralgia (25.9%), hypophosphataemia (23.1%), dry skin (21.8%) and palmar-plantar erythrodysaesthesia syndrome (16.3%).¹

Ends.

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics (ST) is an international biopharmaceutical company providing new specialist therapies and technologies to patients throughout Southeast Asia, as well as in Australia and New Zealand. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About PEMAZYRE^®

PEMAZYRE (pemigatinib) a fibroblast growth factor receptor (FGFR) inhibitor, has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

PEMAZYRE is marketed by Incyte in the United States, Europe and Japan. Incyte has established various license or distribution agreements for Pemazyre in certain geographies and retains all other rights to develop and commercialize pemigatinib outside of the United States.

PEMAZYRE^® is a trademark of Incyte Corporation.

Further Enquiries:

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com 

References

1. PEMAZYRE (pemigatinib) Product Information Australia
2. Abou-Alfa et al. Lancet Oncol 2020;21:671-684

• Singapore’s Health Sciences Authority (HSA) has accepted QINLOCK^® (ripretinib) for evaluation for the treatment of people with 4^th line GIST

• Leading Singapore oncologist has welcomed this key HSA evaluation milestone

• QINLOCK significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall survival in the INVICTUS Phase 3 Study¹

Singapore, 12 July 2022: A novel therapy to treat rare gastrointestinal stromal tumours (GIST) has been accepted for evaluation by Singapore’s Health Sciences Authority.

The proposed indication for the therapy known as QINLOCK (ripretinib) in Singapore is “for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received treatment with three or more kinase inhibitors, including imatinib”.

Dr. Richard Quek, a Singapore-based senior consultant in medical oncology welcomed the evaluation of QINLOCK, saying any new therapy options for rare GIST cancers “can only be good for patients”.

“I would like patients to know that there is a new treatment, even in the advanced setting, that has been shown to prolong the period of disease control and progression-free survival,” Dr Quek said.

“There is still clearly a need to discover new therapies. Despite new treatment options available, advanced GIST is still considered incurable.”

QINLOCK is an oral medication used to treat GIST in people who have received at least three prior treatments. It belongs to a drug class called tyrosine kinase inhibitors and works by blocking specific tumour proliferation pathways.²

A pivotal Phase 3 clinical trial of QINLOCK – the INVICTUS study – demonstrated that QINLOCK was able to significantly reduce the risk of disease progression by 85% (hazard ratio of 0.15, p<0.0001) with a median progression-free survival of 6.3 months in patients administered QINLOCK, compared to 1.0 month in the placebo arm.¹ QINLOCK was associated with clinically meaningful overall survival of 15.1 months vs 6.6 months and reduced the risk of death by 64% (hazard ratio of 0.36). The objective response rate by Blinded Independent Central Review was 9.4% with QINLOCK vs 0.0% with placebo (p=0.0504)¹

In addition, in a long-term follow up analysis of the INVICTUS trial, patients in the QINLOCK arm demonstrated a median overall survival of 18.2 months compared to 6.3 months in the placebo arm and reduced the risk of death by 58% (hazard ratio of 0.41).³

ST Chief Executive Officer Carlo Montagner said the HSA submission follows ST’s success achieving regulatory and reimbursement approval in Australia.

“We look forward to progressing QINLOCK through the appropriate regulatory pathway in Singapore,” as authorised by the HSA, Mr Montagner said.

“Until then, we are committed to ensuring all eligible patients in our region have access at the earliest opportunity via pre-approval access programs where permitted.”

Pending approval in Singapore, eligible GIST patients are being provided an early opportunity to access QINLOCK via an Early Patient Access Program, as per HSA guidelines.

QINLOCK will be commercialised in Singapore under an exclusive agreement from US based Deciphera Pharmaceuticals.

Ends.

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST growth usually begins in the connective tissue in the wall of the affected organ and grows outwards. The common location of GISTs are in the stomach (50 to 60%) and small intestines (30 to 40%) but can occur in any site in the digestive system. Other possible GIST sites are the oesophagus, rectum, and colon. GIST cases are rare and estimated to cause between 0.1% and 3% of GI cancer. The risk of GIST diagnosis increases with age, with GIST incidence peaking among people in their fifties and sixties.⁴

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop to lock the kinase in the inactive state, preventing downstream signalling and cell proliferation. This dual mechanism of action provides broad inhibition of KIT and PDGFRA kinase activity, including wild type and multiple primary and secondary mutations. Ripretinib also inhibits other kinases in vitro, such as PDGFRB, TIE2, VEGFR2, and BRAF.²    

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics (ST) is an international biopharmaceutical company providing new specialist therapies and technologies to patients throughout Southeast Asia, as well as in Australia and New Zealand. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About the INVICTUS Phase 3 Study

INVICTUS is a Phase 3 randomised, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK once daily (n=85) or placebo (n=44). The primary efficacy endpoint was progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001).¹ Secondary endpoints as determined by independent radiologic review using modified RECIST included Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504), which was not statistically significant.¹ QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).¹ In a long-term follow up of 19 months after the primary analysis, QINLOCK also demonstrated a median OS of 18.2 months compared to 6.3 months in the placebo arm and reduced the risk of death by 58% (hazard ratio of 0.41).³ The most common (>2%) grade 3 or 4 treatment related adverse events in the QINLOCK group included lipase increase (5%), hypertension (4%), fatigue (2%), and hypophosphataemia (2%); and in the placebo group, anaemia (7%), fatigue (2%), diarrhoea (2%), decreased appetite (2%), dehydration (2%), hyperkalaemia (2%), acute kidney injury (2%), and pulmonary oedema (2%).¹

Further Enquiries:

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com 

References

1. Blay J-Y et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020; 21: 923-934
2. QINLOCK (ripretinib) TGA approved Product Information
3. Von Mehren M al. Presented at ESMO 2021 virtual meeting, 16-21 September 2021
4. El-Menyar A et al. Diagnosis and management of gastrointestinal stromal tumors: An up-to-date literature J Cancer Res Ther. 2017; 13(6):889- 900

• NERLYNX^® (neratinib) is approved by the Food and Drug Administration of the Philippines 

• Leading regional breast cancer oncologists say the availability of NERLYNX is a ‘great step forward’ for women in the Philippines who have been diagnosed with HER2+ early-stage breast cancer

• Five-year follow-up data shows NERLYNX reduces the risk of invasive disease recurrence by 42% in women with early-stage, HER2+/HR+ breast cancer and who commence therapy within 12 months of completing trastuzumab-based therapy ¹

Singapore, 8 July 2022: A NEW drug shown to significantly reduce the risk of cancer recurrence or death in an aggressive form of breast cancer is now approved by the Food and Drug Administration of the Philippines.

The drug, NERLYNX (neratinib) is an oral medication taken daily for 12 months by women who have been diagnosed with early-stage HER2-positive (HER2+) breast cancer and who have received prior trastuzumab-based therapy.

It has been approved by the Food and Drug Administration of the Philippines “for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.”

The greatest benefit is seen in women who are hormone-receptor positive (HR+) and who initiate NERLYNX therapy within 12 months of completing trastuzumab-based therapy. Their five-year risk of recurrence is reduced by 42% after completing 12 months of NERLYNX therapy.¹

Chair of the Philippines’ Cardinal Santos Medical Center, Dr Ma. Luisa Abesamis-Tiambeng, said the NERLYNX approval was “a great step forward” for women in the Philippines who have been diagnosed with early breast cancer that is both HER2+ and HR+.

Dr Tiambeng commented: “We know that one in four women with this type of breast cancer are still at risk of recurrence, despite treatment with chemotherapy and trastuzumab-based therapy following their initial breast surgery. Following this important approval by the Food and Drug Administration of the Philippines, NERLYNX presents a new opportunity for women in this region to have extended adjuvant therapy to further reduce their chance of a relapse.”

NERLYNX is being made available by independent pharmaceutical company, Specialised Therapeutics (ST).

ST Chief Executive Officer Carlo Montagner said NERLYNX was the first therapy in the company’s therapeutic portfolio to achieve approval in the Philippines.

“There are regulatory nuances in every territory in which we operate, and this latest approval is a testament to the skill of our regulatory team, who are navigating complex jurisdictions,” he said.

“From a patient perspective, this is the first time the women in the Philippines are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence.

“We are pleased to be at the forefront of this new treatment paradigm and look forward to changing outcomes for these women and their families and friends.”

Ends.

About NERLYNX 

NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.²

NERLYNX is the first HER2-targeted medication approved by the U. S Food and Drug Administration (FDA) for the extended adjuvant treatment of adult patients with early-stage HER2+ breast cancer, who have previously been treated with trastuzumab following surgery (i.e., adjuvant trastuzumab-based therapy).⁷ NERLYNX is also the first anti-HER2 treatment to be approved by the European Commission (EC) for the extended adjuvant treatment of adult patients with early-stage HR+ / HER2+ breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.⁸

Extended adjuvant therapy is the next step of treatment that follows adjuvant therapy (treatment after surgery) to further reduce the risk of breast cancer returning.

NERLYNX is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.²

About HER2+ Breast Cancer

Up to 20% of patients with breast cancer tumours over-express the HER2 protein (HER2+ disease) and in the ExteNET study, 57% of patients were found to have tumours that were HR+. HER2+ breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early-stage HER2+ breast cancer returning after surgery, up to 25% of patients treated with trastuzumab-based adjuvant therapy experience recurrence within 10 years, the majority of which are metastatic recurrences.³    

About the ExteNET Study^1,3,4

The ExteNET trial was a double-blind, placebo-controlled, Phase III study of neratinib versus placebo after adjuvant treatment with trastuzumab and chemotherapy in patients with early-stage HER2+ breast cancer.

The ExteNET study randomised 2,840 patients in 41 countries with early-stage HER2+ breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation.

The primary endpoint of the trial was invasive disease-free survival (iDFS) with a 34% reduction in the risk of recurrence and a 2.3% absolute benefit versus placebo at 2 years (HR=0.66; 95% CI: 0.49, 0.90 p=0.008). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p= 0.008). The 5-year iDFS rate for the neratinib arm was 90.2% and the 5-year iDFS rate for the placebo arm was 87.7%.¹ In the overall survival (OS) analysis after a median follow-up of 8.0 years (range, 0-9.8 years), 53 (7.9%) of 670 patients in the neratinib group and 68 (10.2%) of 664 patients in the placebo group of the HR+/≤ 1-year population had died. The hazard ratio of OS was 0.79 (95% CI, 0.55-1.13), and the estimated 8-year OS rates were 91.5% (95% CI, 88.9%-93.5%) in the neratinib group and 89.4% (95% CI, 86.6%-91.6%) in the placebo group of the HR+/≤ 1-year population, giving an absolute between-group difference of 2.1%.⁴

An additional five-year sub-group analysis demonstrated a 42% risk reduction in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab-based therapy.⁵

The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.²

A Phase II CONTROL study investigated various prophylactic antidiarrhoeal regimens for the first 1-2 cycles of neratinib therapy. Data suggest that prophylactic management reduces the incidence, severity and duration of neratinib-associated diarrhoea as compared with events observed in ExteNET.⁶

About Specialised Therapeutics

 Headquartered in Singapore, Specialised Therapeutics (ST) is an international biopharmaceutical company providing new specialist therapies and technologies to patients throughout Southeast Asia, as well as in Australia and New Zealand. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care.

Additional information can be found at www.stbiopharma.com

Further Enquiries:

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com 

References

1. Martin M, et. al. Lancet Oncol. 2017;18(12):1688-1700.
2. The Philippines Nerlynx Product Information.
3. Chan A, et. al. Lancet Oncol. 2016;17(3):367-377.
4. Chan A, et al. Clin Breast Cancer 2021; 21(1):80-91.
5. Gnant M, et al. SABCS 2018 P2-13-01.6.
6. Barcenas CH et al., 2020; 31(9):1223-1230
7. Nerlynx U.S Prescribing Information
8. Nerlynx EU Summary of Product Characteristics

Singapore, 4 July 2022:  International biopharmaceutical company Specialised Therapeutics (ST) has struck an important agreement with highly recognised logistics partner Healthcare Logistics (HCL) to store and distribute its growing portfolio of specialist healthcare products in Australia.

Under the terms of the arrangement, HCL will undertake all critical logistics functions on behalf of ST, including receipt of pharmaceutical products from ST’s international pharmaceutical partners, storage and delivery Australia wide. It will also assist ST with secondary packaging of our products, as well as preparing and delivering clinical trial supplies to key hospitals, pharmacies and wholesalers at sites around Australia and New Zealand.

Commercial terms are not being disclosed, but the arrangement formally takes effect from today.

ST Chief Executive Officer Mr. Carlo Montagner said HCL was carefully and strategically selected for its high standards, state-of-the-art warehousing facilities and successful track record handling complex pharmaceutical products. He said the latest agreement was an extension of an existing alliance ST has with HCL in New Zealand.

“We have already been impressed by HCL’s customer service and solutions focus in New Zealand,” Mr Montagner said. “The extension of this arrangement in Australia further cements our business partnership internationally.”

“As a business, we know HCL is well-versed in the complexities of managing specialty pharmaceutical products.”

“In addition, it is very clear that HCL prioritises the patient – the ultimate recipient of our stored therapies. We are confident this new arrangement will ensure that our medicines are delivered safely and efficiently, so patients are able to access products in a timely fashion – even with a ‘same day’ or ‘next day’ order.”

HCL is part of EBOS Group, which is the largest and most diversified Australasian marketer, wholesaler and distributor of healthcare, medical and pharmaceutical products. EBOS is also a leading marketer and distributor of recognised animal care brands.

HCL Australia Executive General Manager Bradley James said the company was thrilled to build on its valued partnership with Specialised Therapeutics.

“Building strong relationships underpinned by our high-quality standards are at the core of everything we do, and we feel privileged that Specialised Therapeutics has again entrusted us to provide crucial storage and distribution support for their products,” he said.

“Our investment in a new warehouse in Sydney is a prime example of how we strive to deliver leading storage and logistics capability for our clients and meet their expanding needs.”

Ends.

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics (ST) is an international biopharmaceutical company providing new specialist therapies and technologies to patients throughout Southeast Asia, as well as in Australia and New Zealand. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. 

Additional information can be found at www.stbiopharma.com

About EBOS Group

EBOS Group Limited NZBN 9429031998840 (NZX/ASX Code: EBO) is the largest and most diversified Australasian marketer, wholesaler and distributor of healthcare, medical and pharmaceutical products. It is also a leading Australasian animal care brand owner, product marketer and distributor.

Further Enquiries:

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com 

• NERLYNX^® (neratinib) is approved by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA)
• Leading regional breast cancer oncologists say the availability of NERLYNX (neratinib) is a ‘huge step forward’ for Malaysian women who have been diagnosed with HER2+ early-stage breast cancer
• Five-year follow-up data shows NERLYNX reduces the risk of invasive disease recurrence by 42% in women with early stage, HER2+/HR+ breast cancer and who commence therapy within 12 months of completing trastuzumab-based therapy¹

Singapore, 29 March 2022: A NEW drug shown to significantly reduce the risk of cancer recurrence or death in an aggressive form of breast cancer is now available in Malaysia.

The drug, NERLYNX (neratinib) is an oral medication taken for 12 months by women who have been diagnosed with early stage HER2-positive (HER2+) breast cancer and who have received prior trastuzumab-based therapy.

It is approved in Malaysia “for the extended adjuvant treatment of women with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago”.²

The greatest benefit is seen in women who are hormone-receptor positive (HR+) and who initiate NERLYNX therapy within 12 months of completing trastuzumab-based therapy. Their five-year risk of recurrence is reduced by 42% after completing 12 months of NERLYNX therapy.¹

Malaysian breast cancer oncologist Dr Mastura Md Yusof from Cancer Centre at Pantai Hospital Kuala Lumpur said around 2500 women were diagnosed with early-stage breast cancer every year in Malaysia. She describes the availability of NERLYNX as “very welcome for many women and their families”.

“As oncologists treating these patients on the field, we welcome any new therapy that can give benefits to patients,” Dr Mastura said. “We know about thirty percent of early-stage breast cancer patients will relapse in the first three years after standard treatment. Any further treatment that we can provide to further reduce the risk of recurrence in some of these women must be considered.

“Malaysian women typically are very hardworking, and frequently are the main income generators in many households. If they develop breast cancer, we must give them the best shot at life so they can continue to live with dignity, and contribute to their family, work and society.”

NERLYNX is being made available by independent pharmaceutical company, Specialised Therapeutics (ST), in partnership with Zuellig Pharma Sdn Bhd, who will be distributing NERLYNX in Malaysia.

ST Chief Executive Officer Carlo Montagner said NERLYNX represented a new stage of treatment for Malaysian women.

“This is the first time Malaysian women are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence,” he said.

“We are pleased to be at the forefront of this new treatment paradigm and look forward to changing outcomes for these women and their families and friends.”

Ends.

About NERLYNX

NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.²

NERLYNX is the first HER2-targeted medication approved by the FDA as extended adjuvant treatment for early stage HER2-positive (HER2+) breast cancer, for patients who have previously been treated with trastuzumab following surgery (i.e., adjuvant trastuzumab-based therapy). NERLYNX is also the first anti-HER2 treatment to be European Commission (EC) approved as extended adjuvant therapy for early-stage HR+ / HER2-positive breast cancer following adjuvant trastuzumab-based therapy.²

Extended adjuvant therapy is the next step of treatment that follows adjuvant therapy (treatment after surgery) to further reduce the risk of breast cancer returning. 

NERLYNX is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.²

About HER2+ Breast Cancer 

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive.   HER2+ breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early-stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab-based adjuvant therapy experience recurrence.³  

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics (ST) is an international biopharmaceutical company providing new specialist therapies and technologies to patients throughout Southeast Asia, as well as in Australia and New Zealand. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. 

Additional information can be found at www.stbiopharma.com

Further Enquiries:

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com 

References

1. Martin M, et. al. Lancet Oncol. 2017;18(12):1688-1700.
2. Malaysia Nerlynx Product Information. https://quest3plus.bpfk.gov.my/pmo2/detail.php?type=product&id=MAL20076009ACRZ
3. Chan A, et. al. Lancet Oncol. 2016;17(3):367-377.

• QINLOCK^® (ripretinib) now PBS listed for Australian patients
• QINLOCK is the first new reimbursed therapy to treat advanced GIST in more than a decade
• Leading Australian oncologist says the listing will help to “buy patients more time”
• Data shows QINLOCK reduces risk of disease progression by 85%^{1, 2} 

14 November, 2021: AUSTRALIAN cancer patients who have been diagnosed with rare gastrointestinal stromal tumours – GIST – will now have affordable access to a new therapy shown to improve survival, following its listing on the Pharmaceutical Benefits Scheme (PBS).³

The therapy, QINLOCK (ripretinib) is an oral medication and will be available to eligible patients on the PBS from December 1, in a listing described by cancer specialists and patient advocacy groups as “a great relief” for patients.

Leading Australian oncologist Professor John Zalcberg, who is a consultant medical oncologist at Alfred Health and is Head of Monash University’s Cancer Research Program in the School of Public Health, welcomed the reimbursement of QINLOCK, describing it as a “fantastic” result for patients and their families.

Professor Zalcberg commented: “It has been more than 10 years since a new therapy able to treat GIST has been listed on the PBS. QINLOCK is a therapy that can buy patients more time, but the market price of this therapy has meant that until now, it has been out of bounds for most people. This PBS listing will be welcomed by many Australian patients and their families.”

35-year-old Melbourne mother of two Renee Van Beelen was diagnosed with GIST five years ago, only eight weeks after giving birth to her second child. She has had her stomach removed and endured several cancer recurrences. She is relieved another therapy is now accessible.

“It can buy me time, at a price that we can afford for our family,” she said. “We simply would not have been able to come up with thousands of dollars every month. Having QINLOCK listed on the PBS means the world to us, because it means I have another tool in my back pocket to help me watch my children grow up. All I want is to create moments with my family and knowing that this therapy is available on the PBS is a huge relief.”

And Canberra teacher and mother Sarah McGoram, who was given a year to live 25 years ago, says this listing “will have a profound impact on my family.”

Sarah, who has led a national lobby campaign fighting for QINLOCK to be funded, says: “QINLOCK being funded on the PBS can buy me time. It buys me a treatment option that was not otherwise there. That’s all I want. I just want time with my family and time to fight this frustrating disease.”

Rare Cancers Australia Chief Executive Officer Richard Vines said today was “a red-letter day” for the GIST community, as patients previously had no further treatment options after other therapies failed.

“QINLOCK offers hope, it offers time and it offers a future that otherwise they would not have had,” Mr Vines said. “This has been a long time coming for GIST patients and it is a fantastic result.”

QINLOCK belongs to a class of drugs known as tyrosine kinase inhibitors, or TKIs. It works by inhibiting key enzymes linked to tumour growth. It is now reimbursed “for the treatment of patients with advanced metastatic or unresectable GIST who have progressed following treatment with imatinib and sunitinib.” ³

A pivotal Phase 3 clinical trial of QINLOCK – the INVICTUS study – demonstrated that QINLOCK was able to significantly reduce the risk of disease progression by 85% (hazard ratio of 0.15, p<0.0001) with a median progression-free survival of 6.3 months in patients administered QINLOCK, compared to 1.0 month in the placebo arm.¹ In addition, in a long-term follow up analysis, patients in the QINLOCK arm achieved a median overall survival of 18.2 months compared to 6.3 months in the placebo arm and QINLOCK reduced the risk of death by 58% (hazard ratio of 0.42).^{1, 4}

QINLOCK is made available in Australia by independent pharmaceutical company Specialised Therapeutics (ST) under exclusive license from US based Deciphera Pharmaceuticals.

ST Chief Executive Officer Carlo Montagner said it was vital rare cancer patients were provided affordable access to specialist medicines.

“Without PBS reimbursement, most patients would be unable to afford this therapy,” he said. “We are celebrating the PBS listing of QINLOCK and look forward to seeing it make a difference to GIST patients and their families.”

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST growth usually begins in the connective tissue in the wall of the affected organ and grows outwards. The common location of GISTs are in the stomach (50 to 60%) and small intestines (30 to 40%) but can occur in any site in the digestive system. Other possible GIST sites are the oesophagus, rectum, and colon. GIST cases are rare and estimated to cause between 0.1% and 3% of GI cancer in Australia. The risk of GIST diagnosis increases with age, with GIST incidence peaking among people in their fifties and sixties.⁵

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop to lock the kinase in the inactive state, preventing downstream signalling and cell proliferation. This dual mechanism of action provides broad inhibition of KIT and PDGFRA kinase activity, including wild type and multiple primary and secondary mutations. Ripretinib also inhibits other kinases in vitro, such as PDGFRB, TIE2, VEGFR2, and BRAF.²

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About the INVICTUS Phase 3 Study

INVICTUS is a Phase 3 randomised, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK once daily (n=85) or placebo (n=44). The primary efficacy endpoint was progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001).¹ Secondary endpoints as determined by independent radiologic review using modified RECIST included Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)¹. In a long-term follow up of 19 months after the primary analysis, QINLOCK also demonstrated a median OS of 18.2 months compared to 6.3 months in the placebo arm and reduced the risk of death by 58% (hazard ratio of 0.42).⁴ The most common (>2%) grade 3 or 4 treatment related adverse events in the QINLOCK group included lipase increase (5%), hypertension (4%), fatigue (2%), and hypophosphataemia (2%); and in the placebo group, anaemia (7%), fatigue (2%), diarrhoea (2%), decreased appetite (2%), dehydration (2%), hyperkalaemia (2%), acute kidney injury (2%), and pulmonary oedema (2%).¹

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

References:

1. Blay J-Y et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol.2020; 21: 923-934
2. QINLOCK (ripretinib) TGA approved Product Information
3. QINLOCK (ripretinib) PBS Listing https://www.pbs.gov.au/browse/medicine-listing
4. Von Mehren M et.al. Presented at ESMO 2021 virtual meeting, 16-21 September 2021
5. GI Cancer Institute Australia https://gicancer.org.au/cancer/gastro-intestinal-stromal-tumour-gist/#cancer-explanation

Singapore, 22 October 2021: Independent pharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) will partner with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), to launch and distribute two new medicines for its haematology and oncology portfolios, tafasitamab (sold as Monjuvi^® in the United States and Minjuvi^® in Europe) and pemigatinib (Pemazyre^®).

Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply of both products and ST will be responsible for regulatory, distribution and local marketing related activities in Australia, New Zealand and Singapore.

Pemigatinib is approved in the United States, Europe and Japan for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Tafasitamab in combination with lenalidomide is approved in the United States and Europe for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

ST Chief Executive Officer Mr Carlo Montagner said the new products were synergistic with the company’s strong oncology and haematology portfolios, and the new agreement was further endorsement of ST’s regional capabilities.

“We are proud to have been selected to partner with a world-leading biotech of Incyte’s calibre and look forward to these important products in our key regions,” he said.

“Both pemigatinib and tafasitamab address strong unmet needs in rare patient populations. We have extensive experience and a successful track record of working with clinicians and other stakeholders to bring innovative therapies to small patient populations where there is high unmet clinical need. Our teams look forward to working closely with Incyte to ensure all eligible patients have access to these therapies at the earliest opportunity.”

Incyte CEO Hervé Hoppenot said the latest collaboration and partnership provided an important strategic opportunity to further serve the global oncology community, offering innovative new medicines to patients with high unmet needs in Australia, New Zealand and Singapore.

“ST’s expertise in these regions, navigating complex regulatory channels to bring new therapies and technologies to patients with rare cancers, is complementary to our own commitment to positively impact the lives of patients with serious unmet medical needs,” he said. “We look forward to a successful and mutually beneficial partnership, working together with a shared goal of improving patient outcomes.”

Regulatory activities for both products are currently in progress.

Ends.

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (ST) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South-East Asia, as well as in Australia and New Zealand. ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

In January 2020, MorphoSys and Incyte entered into a Collaboration and License agreement to further develop and commercialize tafasitamab globally. Monjuvi^® is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

In the United States, Monjuvi^® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi^® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi^® and Monjuvi^® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi^® in the U.S., and marketed by Incyte under the brand name Minjuvi^® in the EU.

XmAb^® is a trademark of Xencor, Inc.

About Pemigatinib

Pemigatinib (Pemazyre^®) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 that, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has established various license or distribution agreements for Pemazyre in certain geographies and retains all other rights to develop and commercialize pemigatinib outside of the United States.

Pemazyre is a trademark of Incyte.

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

Singapore, 22 September 2021: SINGAPORE patients with an aggressive form of lung cancer (metastatic small cell cung cancer) can now access a new therapy that may improve outcomes.

The drug ZEPZELCA (lurbinectedin) has been provisionally approved by Singapore’s Health Sciences Authority (HSA) “for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing chemotherapy”.¹ 

This means patients who have failed other existing treatment options will now have a further therapeutic option.

ZEPZELCA is the first new therapy approved by the HSA to treat second-line SCLC in more than two decades, and is the third oncology drug in Specialised Therapeutics (ST) portfolio to receive HSA approval.

The Singapore approval follows on from approvals by the US Food and Drug Administration (FDA) decision², as well as the Therapeutic Goods Administration (TGA) in Australia.³

“The new availability of ZEPZELCA will be welcomed by patients, families and the medical community, as we strive to improve patient outcomes for this disease,” Professor Mitchell said.

“With this approval, we now have another option for patients who have progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes.”

The HSA approval of ZEPZELCA has been granted following collaboration with the US FDA via the ‘Project Orbis’ initiative, due to the high unmet clinical need in SCLC. It is based on monotherapy clinical data from an open-label, multi-centre, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.⁶

The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with relapsed SCLC, ZEPZELCA provided an ORR of 35% and a median duration of response of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC)).⁶

The provisional approval is the subject of a further confirmatory study in more than 700 patients with 2L SCLC. This study is expected to be completed in 2025.

ZEPZELCA is being made available in Singapore by independent pharmaceutical company Specialised Therapeutics under exclusive license from its international partner PharmaMar.

Specialised Therapeutics Chief Executive Officer Mr Carlo Montagner said lung cancer was the third most common cancer in Singapore, representing more than 22% of all cancer deaths. SCLC represented between 10 – 15% per cent of all lung cancer diagnoses.^7,8

“We are delighted to be able to provide a new therapy option in Singapore for patients with this difficult to treat cancer,” he said.

“While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.

“We expect that this therapy may now be an option for up to 100 Singapore patients every year and look forward to making a difference for these patients and their families.”

PharmaMar president José María Fernández Sousa-Faro, PhD, said the company was delighted South-East Asian patients would now be provided access to ZEPZELCA.

“We are pleased to bring a new treatment choice to relapsed SCLC patients. “The accelerated approval of ZEPZELCA underscores its potential to fill an unmet need in this often-overlooked SCLC community.”

ZEPZELCA has been available in Singapore via an Early Access Program since July 2020.

Ends.

About SCLC in Singapore

SCLC represents a serious condition. It is a particularly aggressive type of lung cancer related to smoking that represents approximately 10-15% of all lung cancers, accounting for more than 275,000 new cases worldwide every year.^9,10 SCLC is characterised by rapid growth, early dissemination that is often asymptomatic and with acquired resistance to drugs. SCLC is staged into limited-stage or extensive-stage disease. Limited-stage disease is potentially curable with aggressive therapy consisting of concurrent chemoradiotherapy, prophylactic cranial irradiation, and occasionally, surgery.^11,12 However, nearly two-thirds of SCLC patients have extensive-stage disease at diagnosis, which is not curable, and patients are treated with palliative intent, with a median survival of 7 to 11 months after diagnosis and with less than 5% survival at 2 years.^13,14

Lung cancer is the third most common cancer in Singapore and represents 22.3% of all cancer deaths. Between 2014 and 2018, approximately 7,945 new cases of lung cancer were diagnosed in Singapore, with 10-15% of these classified as SCLC (between 150 and 240 new SCLC cases annually).7,8 While the age-standardised incidence rate of all lung cancer has been in decline since the 1970’s (mid-50’s per 100,000 in 1968 to mid-30’s per 100,000 in 2017), the five-year relative survival has seen a moderate increase to approximately 10% in 2017. Globally, the prognosis of patients with SCLC is dismal with a 5-year survival rate of less than 5% and an average overall survival period of only 2–4 months for patients not receiving any active treatment.^11,12

Modern studies, including those of recent immunotherapies, suggest that between 40-60% of patients that receive front-line therapy will be clinically eligible for second-line therapy.^15-18 This suggests that, based on 2014-2018 lung cancer incidence figures from the Singapore Cancer registry8, between 60 to 100 patients would be eligible for second-line SCLC treatment in Singapore.

About ZEPZELCA^® (lurbinectedin)

ZEPZELCA is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.¹

ZEPZELCA or injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. ZEPZELCA is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of ZEPZELCA for this use.

About the Phase II Monotherapy Trial

The Phase 2 trial of ZEPZELCA was an open-label, single-arm study, which enrolled a total of 105 SCLC patients at 26 hospitals in six European countries and the U.S.⁶ In the trial, platinum-sensitive and platinum-resistant patients were treated with ZEPZELCA 3.2 mg/m², administered as a 60-minute IV infusion repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoint, ORR, was 35% and the median duration of response was 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an IRC).⁶ ZEPZELCA was discontinued in 1.9% of patients and was delayed in 30.5% of patients due to an adverse reaction. Dose reductions for an adverse reaction occurred in 25% of patients.⁶

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes YONDELIS^® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

References:

1. ZEPZELCA (lurbinectedin) HSA Approved Singapore Prescribing Information.
2. ZEPZELCA (lurbinectedin) FDA Approved US Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf
3. ZEPZELCA (lurbinectedin) TGA Approved Australian Prescribing Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-02108-1&d=20210914172310101
4. PDQ Adult Treatment Editorial Board. Small Cell Lung Cancer Treatment (PDQ®) Health Professional Version. Published online: May 1, 2019. Available at https://www.ncbi.nlm.nih.gov/books/NBK65909/ (accessed 8 October 2019)
5. Cancer Council https://www.cancer.org.au/about-cancer/types-of-cancer/lung-cancer.html
6. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase basket trial. Lancet Oncol.2020; 21(5):645–654.
7. Singapore Cancer Society. https://www.singaporecancersociety.org.sg/learn-about-cancer/types-of-cancer/lung-cancer.html
8. Singapore Cancer Registry Annual Report 2018. https://www.nrdo.gov.sg/docs/librariesprovider3/default-document-library/scr-annual-report-2018.pdf?sfvrsn=bcf56c25_0
9. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012.Eur J Cancer 2013; 49:1374-403.
10. Slotman B, et al: Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med 2007; 357(7): 664 – 72
11. Stinchcombe TE, Gore EM. Limited-stage small cell lung cancer: current chemoradiotherapy treatment paradigms. Oncologist. 2010;15(2):187–95.
12. Demedts IK, Vermaelen KY, van Meerbeeck JP. Treatment of extensive-stage small cell lung carcinoma: current status and future prospects. Eur Respir J. 2010; 35(1):202–15.
13. Simos D, et al, Third line chemotherapy in SCLC: an international analysis. Clin Lung Cancer 2014; 15 (2): 110-8
14. Pelayo Alvarez M, et al. Chemotherapy versus best supportive care for extensive SCLC. Cochrane Database Syst Rev 2013; 11: CD001990
15. Puglisi M, et al. Treatment options for SCLC – do we have more choice? Br J Cancer 2010; 102 (4): 629-38
16. Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019; 394(10212):1929-1939.
17. Horn L, Mansfield AS, Szczęsna A, et al. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018; 379(23): 2220-2229.
18. Hanna N, Bunn PA Jr, Langer C, et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006; 24(13): 2038-2043.

Singapore, 14 September 2021: AUSTRALIAN patients with an aggressive form of lung cancer (metastatic Small Cell Lung Cancer) can now access a new therapy that may improve outcomes.

The therapy, ZEPZELCA™ (lurbinectedin) has been approved by the Therapeutic Goods Administration (TGA) “for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy”.¹

This means patients who have failed other existing treatment options will now be able to access another line of therapy.

ZEPZELCA is the first new therapy approved by the TGA to treat second-line SCLC in more than two decades.

Australian lung cancer oncologist Professor Paul Mitchell from the Olivia Newton-John Cancer and Wellness and Research Centre said SCLC was particularly aggressive and more than two-thirds of patients were diagnosed with extensive stage disease. He said fewer than 5% of these patients currently survived more than five years post diagnosis. ^3,4

“The new availability of ZEPZELCA will be welcomed by patients, families and the medical community, as we strive to improve patient outcomes for this disease,” Professor Mitchell said.

“With this approval, we now have another option for patients who have progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes.”

The TGA approval of ZEPZELCA has been granted under a provisional regulatory pathway. The US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) collaborated via ‘Project Orbis’ to accelerate availability to Australian patients.

ZEPZELCA’s approval is based on clinical data from an open-label, multi-centre, single-arm phase II study in 105 adult patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.²

The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with relapsed SCLC, ZEPZELCA provided an Overall Response Rate (ORR) of 35% and a median duration of response of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC).²

The provisional approval is the subject of a further confirmatory study in more than 700 patients with 2nd line SCLC including some Australian sites. This study is expected to be completed in 2025.

ZEPZELCA is being made available in Australia by the independent pharmaceutical Company, Specialised Therapeutics (ST), under exclusive license from international partner, PharmaMar.

ST Chief Executive Officer Mr Carlo Montagner said the approval of ZEPZELCA would potentially make a difference for around 400 Australian patients annually who had run out of treatment options.

“We are delighted to be able to provide a new therapy option for patients with this difficult to treat cancer,” he said.

“While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.

“Our mission has always been to provide therapies in areas of unmet need and SCLC is certainly one of these areas. We look forward to making a difference for these patients and their families.”

PharmaMar president José María Fernández Sousa-Faro, PhD, said the Company was delighted Australian patients would now be provided access to ZEPZELCA.

“We are pleased to bring a new treatment choice to relapsed SCLC patients. “The accelerated approval of ZEPZELCA underscores its potential to fill an unmet need in this often-overlooked SCLC community.”

ZEPZELCA is currently available in Australia via a Special Access Program.

Commercial supplies of ZEPZELCA will commence early 2022.

Ends.

About Small Cell Lung Cancer (SCLC)

SCLC is a particularly aggressive type of lung cancer that represents approximately 10-15% of all lung cancers,³ accounting for more than 275,000 new cases worldwide every year. In Australia, around 1,900 patients are diagnosed annually with the disease,⁴ which is characterised by rapid growth, early dissemination that is often asymptomatic and with acquired resistance to drugs². SCLC is staged into limited-stage or extensive-stage disease. Limited-stage disease is potentially curable with aggressive therapy consisting of concurrent chemoradiotherapy, prophylactic cranial irradiation, and occasionally, surgery. However, nearly two-thirds of SCLC patients have extensive-stage disease at diagnosis, which is not curable, and patients are currently treated with palliative intent, with a median survival of 7 to 11 months after diagnosis and with less than 5% survival at 2 years.^5,6

About ZEPZELCA™ (lurbinectedin)

ZEPZELCA also known as PM1183, is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.¹

ZEPZELCA 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. ZEPZELCA is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of ZEPZELCA for this use.

About the Phase II Monotherapy Trial

The Phase II trial of ZEPZELCA was an open-label, single-arm study, which enrolled a total of 105 SCLC patients at 26 hospitals in six European countries and the U.S.² In the trial, platinum-sensitive and platinum-resistant patients were treated with ZEPZELCA 3.2 mg/m², administered as a 60-minute IV infusion repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoint, ORR, was 35% and the median duration of response was 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an IRC).² Serious adverse reactions in ≥3% of patients included pneumonia, febrile neutropenia, neutropenia, respiratory tract infection, anaemia, dyspnoea, and thrombocytopenia. ZEPZELCA was discontinued in 1.9% of patients and was delayed in 30.5% of patients due to an adverse reaction. Dose reductions for an adverse reaction occurred in 25 percent of patients.²

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes YONDELIS^® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

References:

1. ZEPZELCA (lurbinectedin) Australian Prescribing Information.
2. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase basket trial. Lancet Oncol. 2020 May;21(5):645–654.
3. PDQ Adult Treatment Editorial Board. Small Cell Lung Cancer Treatment (PDQ®) Health Professional Version. Published online: May 1, 2019. Available at https://www.ncbi.nlm.nih.gov/books/NBK65909/ (accessed 8 October 2019)
4. [ii] Cancer Council https://www.cancer.org.au/about-cancer/types-of-cancer/lung-cancer.html
5. Simos D, et al, Third line chemotherapy in SCLC: an international analysis. Clin Lung Cancer (2014) 15 (2): 110-8
6. Pelayo Alvarez M, et al. Chemotherapy versus best supportive care for extensive sclc. Cochrane Database Syst Rev (2013) 11: CD001990

Singapore, 9 September 2021: A globally regarded sarcoma therapy that has been shown to improve progression free survival¹ is now being re-introduced in key regions of South-East Asia by independent pharmaceutical company Specialised Therapeutics Asia (STA).

The compound YONDELIS^® (trabectedin) will be available to advanced sarcoma patients via their treating oncologists in Singapore, Malaysia and Brunei, following a license agreement between STA and its international pharmaceutical partner, PharmaMar S.A.

YONDELIS has been approved in Singapore, Malaysia and Brunei since 2009 and was previously provided to patients in these regions under a separate pharmaceutical arrangement with former product licensee, Janssen Products, L. E. Full marketing authorisation has now been formally transferred to STA.

YONDELIS – which has been shown to improve progression-free survival when used subsequent to anthracycline-based therapy for patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS)¹ – is approved in Singapore and has been available to patients in the United States since 2015,² and in Europe since 2007.³

Malaysian sarcoma specialist Dr Aminudin Rahman Bin Mohd Mydin, Consultant Clinical Oncologist at the KPJ Damansara Specialist Hospital, welcomed the renewed availability of YONDELIS for appropriate patients in South East Asia.

Dr Aminudin commented: “This is exciting news. YONDELIS is an established therapy that has already been extensively used globally to treat advanced sarcoma patients in South East Asia and globally.

“We expect that the reintroduction of this important therapy in key South East Asian regions will provide a new treatment option for many of our patients, as we strive to provide new therapy options and improve outcomes.”

STA Chief Executive Officer Mr Carlo Montagner said YONDELIS had been previously available to South East Asian patients and is recognised as a global standard of care therapy.

Mr Montagner commented: “Our company has a strong and extensive foundation in oncology and this product is a valuable inclusion to our therapeutic portfolio. We look forward to working with the sarcoma community in multiple regions of South East Asia to improve access to YONDELIS and ensure that it is considered as a new therapy option for all appropriate patients.”

STA markets YONDELIS under an exclusive license arrangement with an international partner, PharmaMar.

Ends.

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. Additional information can be found at www.stbiopharma.com

About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company focused on oncology and committed to research and development, taking its inspiration from the sea to discover molecules with antitumor activity. It is a company seeking innovative products to provide health care professionals with new tools to treat cancer. Its commitment to patients and to research has made it a world leader in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes YONDELIS^® in Europe and has other clinical stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14.

About YONDELIS^® (trabectedin)

YONDELIS^® (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing tumor cells from multiplying and is approved in 76 countries in North America, Europe, South America and Asia for the treatment of advanced soft-tissue sarcomas as a single-agent, and in 69 countries for relapsed ovarian in combination with DOXIL^®/CAELYX^® (doxorubicin HCl liposome injection).

The approval was based on the results of a pivotal phase 3, randomised, open-label controlled study which evaluated YONDELIS versus dacarbazine in over 500 patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen. LPS and LMS are subtypes of soft tissue sarcoma (STS) and represent more than 35% of all STS cases.⁴

The median progression-free survival (PFS) among the YONDELIS treatment group was 4.2 months compared to 1.5 months in the dacarbazine treatment group, representing a 45% reduction in the risk of disease progression or death with YONDELIS (HR=0.55; 95% CI: 0.44 – 0.70; p<0.001).¹

Among the 340 patients who received YONDELIS and were included in the safety analysis in the randomised trial, the most common (≥20%) adverse reactions were nausea (73%), fatigue (67%), vomiting (44%), constipation (36%), decreased appetite (34%), diarrhoea (34%), dyspnoea (25%), peripheral oedema (24%) and headache (23%). The most common (≥20%) laboratory abnormalities were neutropenia (49%), increased alanine transaminase (ALT) (45%), anaemia (39%), increased aspartate aminotransferase (AST) (35%), thrombocytopaenia (30%) and increased blood alkaline phosphatase (20%).¹

About Soft Tissue Sarcoma

Soft tissue sarcoma is a rare type of cancer that forms as a painless lump (tumour) in any one of the soft tissues connecting all the organs and body structures – including fat, muscle, nerves, deep skin tissue, blood vessels and the tissue surrounding joints (synovial tissue). Soft tissue sarcomas commonly develop in the thigh, shoulder and pelvis and may sometimes develop in the abdomen or chest.⁵

Metastatic or locally advanced STS is generally considered incurable, with the mainstay of treatment being systemic chemotherapy. For some patients with limited disease burden however, long-term remission can be achieved through a multimodality approach involving medical, surgical and radiation therapy.⁵

YONDELIS is a registered trademark of PharmaMar SA. YONDELIS is under license from PharmaMar SA.

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

References:
1. Demetri G. et al. J Clin Oncol. 2016; 34(8): 786-793
2. Barone A. et al. Clin Cancer Res; 2017; 23(24): 7448-7453
3. YONDELIS (trabectedin) European Medicines Agency Summary of Product Characteristics
4. Cancer Council Victoria Fact Sheet – Soft tissue sarcoma. Available at https://www.cancervic.org.au/cancer-information/types-of-cancer/soft_tissue_cancers/soft-tissue-cancers-overview.html. Last Accessed: October 2019.
5. Bae S. et al. Clin Sarcoma Res. 2016; 6:11