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

• QINLOCK significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall survival in the INVICTUS Phase 3 Study^1,2

Singapore, 8 May 2023: Independent biopharmaceutical company Specialised Therapeutics Asia (ST) is pleased to announce that a new therapy to treat rare gastrointestinal stromal tumours (GIST) shown to improve survival has been approved for use in Singapore.

The therapy, QINLOCK (ripretinib) is now approved by the Health Sciences Authority (HSA) “for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib, sunitinib, and regorafenib”.

Singapore-based senior consultant in medical oncology Dr Richard Quek said QINLOCK represented a major treatment advancement for patients with advanced GIST.

“Since 2013, despite multiple attempts and studies, no therapy was shown to be effective for 4^th line GIST patients whose cancers have progressed on existing treatment, until the discovery of QINLOCK,” Dr Quek said.

In the pivotal INVICTUS study that led to QINLOCK’s approval, QINLOCK was shown to significantly delay cancer progression.

“This approval in Singapore clearly provides an opportunity for us to improve the outcomes of our GIST patients who are refractory to the current existing treatment.”

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 using modified Response Evaluation Criteria in Solid Tumors (RECIST) was 9.4% with QINLOCK vs 0.0% with placebo (p=0.0504).^1,3

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 59% (hazard ratio of 0.41).The objective response rate was 11.8% with QINLOCK vs 0.0% with placebo.³

ST Chief Executive Officer Carlo Montagner said the Singapore approval followed the recent approval of QINLOCK in New Zealand, as well as regulatory and reimbursement approval in Australia.

“Achieving these critical regulatory milestones is testament to the dedication of our regulatory teams to make QINLOCK available to all eligible patients in Singapore who are impacted by this rare gastrointestinal cancer.”

ST commercialises QINLOCK in Singapore under an exclusive distribution agreement from US based Deciphera Pharmaceuticals.

Further Inquiries can be directed to ST Senior Manager Communications and Corporate Affairs Emma Power on + 65 31589910 epower@stbiopharma.com

About GIST

Gastrointestinal stromal tumour (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 GIST is 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. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.^5,6

About Specialised Therapeutics

Headquartered in Singapore, Specialised Therapeutics (ST) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients in Australia, New Zealand and across South-East Asia. 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. Our mission is to provide therapies that would otherwise not be available to communities in our regions. 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 in the QINLOCK arm 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) compared to placebo.¹ Secondary endpoints included Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST 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 OS 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 59% (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%).^1,4

References 

1. Blay JY, Serrano C, Heinrich MC 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) HSA Approved Product Information, April 2023
3. von Mehren M, Heinrich M, George S, et al. Ripretinib as ≥4th‑line treatment in patients with advanced gastrointestinal stromal tumour (GIST): Long-term update from the phase 3 INVICTUS study. Poster presented at: 2021 European Society for Medical Oncology Virtual Meeting; September 16‑21, 2021.

1. GI Cancer Institute Australia https://gicancer.org.au/cancer/gastro-intestinal-stromal-tumour-gist/#cancer-explanation

5. Smith BD, Kaufman MD, Lu WP et al. Ripretinib (DCC-2618) is a switch control kinase inhibitor of a broad spectrum of oncogenic and drug-resistant KIT and PDGFRA variants. Cancer Cell 2019; 35(5):738–751.
6. Bauer S, Heinrich MC, George S et al. Clinical Activity of Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumor Harboring Heterogeneous KIT/PDGFRA Mutations in the Phase III INVICTUS Study. Clin Cancer Res. 2021;27(23): 6333-6342.

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.

The following presentations may contain off-label content and data concerning products not currently registered in Australia. Specialised Therapeutics does not recommend or endorse off-label use or use of products that are not registered in Australia. These videos are intended for healthcare professionals for informative purposes only.

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The following presentations may contain off-label content and data concerning products not currently registered in Australia. Specialised Therapeutics does not recommend or endorse off-label use or use of products that are not registered in Australia. These videos are intended for healthcare professionals for informative purposes only.

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The following presentations may contain off-label content and data concerning products not currently registered in Australia. Specialised Therapeutics does not recommend or endorse off-label use or use of products that are not registered in Australia. These videos are intended for healthcare professionals for informative purposes only.

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The following presentations may contain off-label content and data concerning products not currently registered in Australia. Specialised Therapeutics does not recommend or endorse off-label use or use of products that are not registered in Australia. These videos are intended for healthcare professionals for informative purposes only.

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The following presentations may contain off-label content and data concerning products not currently registered in Australia. Specialised Therapeutics does not recommend or endorse off-label use or use of products that are not registered in Australia. These videos are intended for healthcare professionals for informative purposes only.

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The following presentations may contain off-label content and data concerning products not currently registered in Australia. Specialised Therapeutics does not recommend or endorse off-label use or use of products that are not registered in Australia. These videos are intended for healthcare professionals for informative purposes only.

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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 and Melbourne, Australia, 4 April, 2017: Independent pharmaceutical company Specialised Therapeutics Asia (ST Asia) will today relaunch a product used to relieve the pain of oral mucositis, a condition that can affect cancer patients undergoing chemotherapy and/or radiotherapy.

GELCLAIR is a bio-adherent oral gel that works by creating a protective film in the mouth, providing durable relief for the painful mouth ulcers that characterise the condition, as well as improving a patient’s ability to eat, drink, swallow and speak.^1-3

ST Asia will market and distribute the product under license from partner, Helsinn Healthcare SASwitzerland.

Chief Executive Officer Mr Carlo Montagner said GELCLAIR was a welcome inclusion to the company’s expanding oncology and supportive care portfolio.

“This product has been available in Australia before, but has been in hiatus since 2015,” he said.

“We know there is continued demand for this important supportive care product and we are delighted to make GELCLAIR available once more to patients suffering from oral mucositis in Australia.”

Internationally regarded oral mucositis expert Professor Dorothy Keefe said the condition could be extremely debilitating, even leading to malnutrition in some cases, with 20 to 40% of patients receiving conventional chemotherapy affected, as well as up to 100% of patients receiving radiation therapy for head and neck cancer.⁴

“Pain in your mouth, or ulceration in your mouth, makes it hard to eat and to swallow,” Professor Keefe said.

“Both of these factors have an impact on quality of life and people can lose 5-10% of their body weight if they are badly affected. GELCLAIR provides a protective barrier that reduces the pain experienced by patients, which is an important part of oral mucositis management.”

Australian journalist and broadcaster Julie McCrossin suffered the debilitating effects of oral mucositis while undergoing treatment for oropharangeal cancer. She described the damage inside her mouth as “catastrophic”.

“I would highly recommend GELCLAIR as a soothing, nurturing mouth treatment that helped me both physically and psychologically in my recovery, when I was suffering the pain and discomfort of treatment for throat cancer,” she said.

“With GELCLAIR, I actually felt it was helping me to start the road to recovery because I felt better. When you are going through weeks and weeks of trauma to your soft tissue, that is worth a million bucks.”

GELCLAIR is available without prescription. Ordering information is available at  www.STAbiopharma.com/gelclair. GELCLAIR can be purchased online only at http://www.chemistwarehouse.com.au or http://www.epharmacy.com.au

About Specialised Therapeutics Asia

Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international biopharmaceutical company established to provide pioneering healthcare solutions to patients throughout South East Asia, as well as in Australia and New Zealand. The company is a close affiliate of Specialised Therapeutics Australia (STA), which also collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. ST Asia is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, neurology, urology and ophthalmology. Additional information can be found at www.STAbiopharma.com

About Gelclair

Gelclair^® is a viscous oral gel for the management and relief of pain associated with oral lesions, particularly oral mucositis/stomatitis, which may be caused by chemotherapy or radiation therapy and irritation from oral surgery.¹ Gelclair^® forms a protective coating over the oral mucosa which shields exposed or sensitised nerve endings from over-stimulation and provides oral pain relief.^1-3 It does not irritate or sting and is non-numbing.¹

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a broad development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Ireland and the US, a representative office in China as well as a product presence in about 90 countries globally. For more information, please visit www.helsinn.com.

References:

1. Gelclair^® Pack Insert. Prepared March 2016
2. Vokurka S et al. The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation. Med Sci Monit 2011; 17(10): CR572-CR576
3. Lindsay G et al. The clinical effectiveness of Gelclair in the management of oral mucositis. Aust Nurs J. 2009; 16(9): 30-33
4. Lalla RV et al. MASCC?ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. Cancer 2014; 120(10): 1453-1461

Media Inquiries:

ST Asia Communications Manager Emma Power +61 419 149 525