The Daily Telegraph: 22 February, 2020

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THE DAILY TELEGRAPH

By Sue Dunlevy 22 February 2020

Tussle over cancer test

Rejection angers support group

A $5000 test that can indicate whether a breast cancer patient needs chemotherapy has been rejected for a government subsidy, even though it would mean thousands of women could avoid the harrowing treatment.

The government’s Medical Services Advisory Committee said there was not enough evidence to support a Medicare rebate for the test.

Breast cancer support groups are furious with the decision, which has also shocked at least one US expert.

“I think it’s a mistake,” Boston’s Dama Faber Institute expert Dr Eric Winer said. In the US, all insurers paid for the genetic test for women with HER2-positive breast cancer when the cancer had not spread to the patient’s lymph nodes, he said.

The Oncotype DX test analyses 21 genes from a breast tumour and can help predict the risk that cancer may recur and the likely benefit chemotherapy may have in reducing that risk.

The test, performed in a single lab in the US, has not been approved by authorities such as the US Food and Drug Administration, nor by the Australian Therapeutic Goods Administration.

Specialised Therapeutics Australia Pty Ltd applied for had public funding of the Oncotype DX test in Australia but was rejected this week.

MSAC advised that the evidence “did not give the committee confidence that the test would identify those patients who could safely avoid chemotherapy”.

Breast Cancer Network Australia was disappointed the test had been rejected. “If we can identify those people who will benefit from not having chemotherapy, it is essential that we save them from over-treatment,” CEO Kirsten Pilatti said, adding chemotherapy has significant long-term impacts on patients’ health.

Kari Svensen (pictured) was able to afford the genetic test when diagnosed with breast cancer five years ago. The now 73-year-old from St Ives said it found she didn’t need chemotherapy and instead she underwent radiation treatment — and is still cancer-free.

“I fervently wish this test was available to all Australian women,” she said.

 




Breast Surgeon Jane O’Brien discusses Oncotype DX

Respected Australian breast cancer surgeon Jane O’Brien discusses the Oncotype DX breast cancer assay.

Click on the video banner above for more.

 




ST COVID-19 Update

Like all companies globally, ST is closely monitoring the COVID-19 pandemic. In any kind of health crisis, all pharmaceutical companies must contribute their expertise to find answers. A key ST partner is Spanish company PharmaMar, which has announced its novel marine-derived multiple myeloma compound is showing encouraging laboratory results as a promising COVID-19 target. ST hopes to engage with some of Australia’s most-respected research authorities to ensure this compound is made available for trial purposes at the earliest opportunity. We also wish to assure our customers that ST has an ample supply of its oncology medicines and we do not foresee any shortages or any impact to patients.

 

See below for full PharmaMar press release.

PharmaMar reports positive results for APLIDIN® against coronavirus HCoV-229E

  • These studies have been carried out at the National Biotechnology Centre (Centro Nacional de Biotecnología) of the Spanish National Research Council (CSIC).
  • PharmaMar will contact regulatory authorities to analyze the possibilities of studies on patients infected with Covid-19.

Madrid, March 13th, 2020. PharmaMar (MSE:PHM) reports that the in vitro studies results of APLIDIN® (plitidepsin) on the human coronavirus HCoV-229E, which has a multiplication and propagation mechanism very similar to COVID-19 , have been positive with a potency of the nanomolar order. These studies have been carried out at the National Biotechnology Centre (Centro Nacional de Biotecnología) of the Spanish National Research Council (CSIC) by Dr Luis Enjuanes, Dr Isabel Solá and Dr Sonia Zúñiga.

These results confirm the hypothesis that the therapeutic target of APLIDIN® (plitidepsin), which is EF1A, is key to the multiplication and spread of the virus.

With these data, PharmaMar will contact regulatory authorities to analyze the possibilities of studies on patients infected with COVID-19 .

Legal warning

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

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.

Media Contact

Alfonso Ortín – Communications Director aortin@pharmamar.com Mobile: +34 609493127
Miguel Martínez-Cava – Communication Manager mmartinez-cava@pharmamar.com Mobile: +34 606597464
Phone: +34 918466000
Capital Markets & Investor Relations:
José Luis Moreno – Director
investorrelations@pharmamar.com
Phone: +34 914444500
Or please visit our website at www.pharmamar.com

 




Philanthropy: MZFF recognised at TLC Ambulance Launch

The MZFF is extremely proud to be a foundation sponsor of the TLC Ambulance Project – an initiative developed by TLC for Kids in collaboration with Ambulance Victoria. This project will enable terminally ill children to be transported to a final destination of their choice – under the care of a full volunteer ambulance crew. The MZFF has donated $150,000 over three years to help bring this project to life. ST co-founder Bozena Zembrzuski was invited to speak at the official ambulance launch.

Click on the video banner above for more.

 




Specialised Therapeutics Signs Exclusive Deal for New Haematology Drug

Singapore, 18 December, 2019: Independent pharmaceutical company Specialised Therapeutics Asia (STA) has signed an exclusive license deal with US-based Onconova Therapeutics (NASDAQ: ONTX), securing commercialisation rights to a new therapy for the treatment of Myelodysplastic Syndrome (MDS).

The drug, known as rigosertib, is currently in a Phase 3 clinical trial to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who have progressed on, failed to respond to, or relapsed after first-line treatment. The trial is over 90% enrolled and has clinical trial sites open in Australia.

STA Chief Executive Officer, Mr Carlo Montagner, said patients with high-risk MDS had limited treatment options following currently available first-line treatment.

“There is no currently approved treatment following failure of standard chemotherapy with hypomethylating agents. Patients are left with the option of entering clinical trials if available, or supportive care,” he said.

“If approved, rigosertib would address a clear unmet medical need and may be a valuable inclusion to the STA therapeutic portfolio.”

“We are delighted to enter into this collaboration with Onconova and look forward to the results of the ongoing phase III INSPIRE trial of intravenous (IV) rigosertib.”

MDS includes a group of diseases which impact the production of normal blood cells in the bone marrow. MDS is more common in elderly people, with 90% of patients diagnosed over age 60, although it can present at any age.1

Onconova Therapeutics’ President and Chief Executive Officer Dr Steven Fruchtman commented: “We are pleased to partner with Specialised Therapeutics Asia, which has a strong track record of commercialising new products in oncology and haematology across Australia and New Zealand, We look forward to working together and following a successful readout of the ongoing INSPIRE Trial, potentially providing rigosertib as a new therapeutic option for patients diagnosed with MDS.”

 

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 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 Onconova Therapeutics, Inc.

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company discovering and developing novel small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS). Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com.

 

About Myelodysplastic Syndromes

MDS is a group of blood disorders that affect bone marrow function, whereby the bone marrow cells appear dysplastic and their capacity to produce cells is defective. As a result, patients with MDS have low blood cell counts and require frequent blood transfusions. In approximately one-third of patients, higher-risk MDS can progress to acute myeloid leukaemia (AML).

The Leukemia Foundation of Australia estimates that an incidence of between four to five per 100,000 of the population. However, in patients over the age of 60, this increases to anything from 20 to 50 per 100,000.1

 

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model described rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: “A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling.” Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

 

About the INSPIRE Phase 3 Clinical Trial

The INternational Study of Phase 3 IV RigosErtib, or INSPIRE, clinical trial was finalised following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomised, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. This time frame optimises the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomised at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

  • • STA secures exclusive commercialisation rights for AU and NZ
  • • Rigosertib is a promising new compound to treat Myelodysplastic Syndrome, which has limited treatment options

 

Further Inquiries

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

 

References

  1. Leukaemia Foundation website accessed 17 December 2019 https://www.leukaemia.org.au/disease-information/myelodysplastic-syndromes/

 




New Early Breast Cancer Drug Approved by Singapore Health Sciences Authority

Singapore, 3 December, 2019: A NEW breast cancer drug shown to significantly reduce the risk of cancer recurrence has received approval in Singapore – at least six months ahead of its expected schedule.

The drug, NERLYNX (neratinib), is an oral medication taken by women with breast cancer who have had surgery, chemotherapy and prior trastuzumab-based therapy.

It has been shown to significantly reduce the ongoing risk of recurrence in HER2+ early breast cancer patients,2   with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy. For these women, the five-year risk of recurrence is reduced by up to 42%.1

NERLYNX is being made available in the region by independent pharmaceutical company, Specialised Therapeutics Asia (STA) under exclusive license from Puma Biotechnology Inc.

Already 13 women in Singapore have been treated with NERLYNX since it was made available recently via a special access program. The number of patients on therapy is now expected to rise.

The HSA approval is “for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy”.

STA Chief Executive Officer Mr Carlo Montagner said the decision to approve NERLYNX in Singapore was a key milestone for the company.

“NERLYNX is the first drug in our portfolio to be approved by the HSA for commercialization in Singapore,” he said.

“We look forward to extending the reach of this medicine, with regulatory dossiers also submitted in Malaysia, Brunei and the Philippines.”

Professor Arlene Chan was the lead investigator and primary author in the pivotal Phase 3 trial of NERLYNX, ExteNET.2

Professor Chan said its availability in Singapore and other regions would be “a huge step forward” to further reduce the risk of cancer recurrence in local women diagnosed with HER2+ early breast cancer.

“Despite the clear proven benefit of standard of care chemotherapy and trastuzumab therapy, women diagnosed with early-stage HER2+ breast cancer are still at risk of disease recurrence,” Professor Chan said.

“This drug provides women with an opportunity to remain disease-free who may otherwise have had a recurrence.”

Singapore health data shows that breast cancer is the most common cancer that affect women in the country, accounting for almost 30% of all cancer cases. It is estimated that one in 15 women will be diagnosed with breast cancer before age 75.3

 

About NERLYNX4

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

NERLYNX is the first HER2-targeted medication approved by the Australian TGA, the US Food and Drug Administration (FDA)4 and the European Medicines Agency (EMA)5 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).

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.

 

About HER2+ Breast Cancer

Approximately 20% to 25% of breast cancer tumours over-express the HER2 protein. 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 24% of patients treated with trastuzumab experience recurrence.6

 

About the ExteNET Study2,7

The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer.

The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive 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). 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%.7

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.7

Puma is conducting a Phase 2 CONTROL study investigating various prophylactic anti-diarrhoeal regimens for the first 1-2 cycles of neratinib therapy. Emerging data suggest that prophylactic management reduces the incidence, severity and duration of neratinib-associated diarrhoea as compared with events observed in ExteNET.

 

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 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.

  • • NERLYNX® (neratinib) now approved in Singapore for HER2+ breast cancer patients following adjuvant trastuzumab-based therapy
  • • NERLYNX is the first therapy in the Specialised Therapeutics’ portfolio approved in SE Asia
  • • Five-year follow up data show NERLYNX reduces 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

Additional information can be found at www.stbiopharma.com

 

Further Inquiries

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

 

References

  1. Gnant, M et al. Presented at the 41st Annual San Antonia Breast Cancer Symposium (SABCS) Dec 4-8, 2018, San Antonia, TX.
  2. Chan A et.al. Lancet Oncol. 2016;17(3):367-77
  3. Singapore Cancer Registry Interim Annual Report 2010 – 2014 (available online)
  4. NERLYNX (neratinib) US Product Information https://www.accessdata.fda.gov/drugsatfda_docs/lab
  5. NERLYNX (neratinib) European Summary of Product Characteristics
  6. Goldhirsch A et al. Lancet.2013;382:1021-1028
  7. Martin M et. Al. Lancet Oncology 2017; 1-13

 




Logistics: How ST Transports Specialty Medicines

Specialised Therapeutics ensures its specialty medicines are transported seamlessly and reliably. Sophisticated planning makes this happen. Our Quality Assurance Manager and GxP Associate David Wilson explains below.

 


 

OUR CAPABILITY: Specialised Therapeutics’ Quality Assurance Manager David Wilson explains how we transport specialist medicines to patients around the world

What are the main considerations ST must take into account when transporting specialty medicines?

There are a few important issues.  First and foremost, we need to ensure that our medicines are securely transported and that they remain at the correct temperature for the entire journey. This requires sophisticated planning and monitoring. Appropriate physical and environment protection containers are employed and our transporters are carefully selected for their expertise in this area. Importantly, we must be mindful that all relevant export and import permits are up to date to avoid airport delays.

 

Are our products fragile? Do they need to be handled with kid-gloves, and why?  What are some of the primary considerations?

Generally, our products are designed to be rugged when transported.  The most important issues are environment control and having them in transit for a short time.

 

How do we assure our partners that we will manage a quality, timely delivery at all times?

We have experienced, reliable transport sub-contractors both internationally and within Australia, who have demonstrated high-level expertise.  Domestically, we aim for overnight deliveries to major centres and overnight plus one day to more remote centres. Outside of Australia, we use several different service providers, all of whom are experts in their fields.

 

What sorts of procedures does ST have in place to ensure seamless, timely and safe deliveries?

Complex products require sophisticated planning, both prior to deliver and on an on-going basis. We continually demand and carry out audits of our key service providers  to ensure all deliveries are optimally managed.

 

What would you say to our partners and potential partners about our logistics and distribution capability in this complex environment?

I believe our procedures and policies around the delivery of specialist medicines are world class. Our procedures are rigorously scrutinised to ensure we are meeting global best practice standards. We don’t develop products in-house so we are ‘caretaking’ the products of our international partners. This responsibility is one we don’t take lightly and our commitment is to champion these products in our regions and ensure they are delivered seamlessly. For this reason, we only engage carefully selected, specialist operators to handle our products.

 

Finally, how does ST select logistics partners?

We select local and international logistics partners with demonstrated capability in the pharmaceutical industry.

From there, we create a short-list and conduct a through due-diligence operation to ensure all our requirements are met. When we have selected final contenders we visit their operations to see first-hand if they are the right fit and we then work through a list of acceptance criteria.

The final step is a qualification audit to accept a partner company into our list of approved suppliers. We are confident we have the right companies in place to deliver our medicines in a way that meets all international standards demanded by global pharma companies.

 




Brain Cancer Awareness Week

Kate’s Story

Royal Melbourne Hospital Head of Neurosurgery Associate Professor Kate Drummond toyed with the idea of teaching and science before finding her way into medicine. Born and bred in Sydney, she credits her parents for inspiring her academic achievement, with their never-ending encouragement instilling a firm belief she could do anything. And while brain matter is interesting enough, it is the people she treats every day who matter most. In this piece, she explains her motivation and outlines her next mission to improve global health.

 

You were the first person in your family to attend university. What inspired this brilliant career?

I don’t think it was anything other than parents who were just totally encouraging. I was the long-awaited child of adoptive parents. They had been waiting for me for a long time and my Mum and Dad poured all their love into me. I was read to, constantly encouraged and told I could do anything.  It did not strike me at the time, but this sort of culture of achievement was built into me and encouraged. Of course I would go to university! My family did not have medical backgrounds themselves. My mother teaches piano and my father started out as a draftsman but then worked in building management for fire protection. There are no medical people in my family at all.

It was not right until the end of school, until a teacher said to me, ‘If you study hard you might get into medicine’. I thought it sounded interesting, but I was planning on teaching or maybe science. It was not until the end of school that I even considered medicine. I estimated I would need 430 out of 500 in the HSC to get into medicine at Sydney University. I had not hit 400 in my trials, but I got 431 in the finals. It was a bit of a late decision!

 

How did you find it initially?

I really struggled at the beginning. We did not start out training in hospitals. The first two and a bit years were sitting in a lecture theatre, learning about comparative biology and other dry basic science topics. It was not until I started seeing patients that I thought ‘okay, this is what I want to do’. I started out wanting to be an obstetrician and then I delivered a baby (which really changed my mind!). Seriously though, there are a lot of things about it that made me realise it was not going to be for me. There are a lot of moral dilemmas in obstetrics. I did quite like the gynaecological surgery in my rotation. I intended on doing general surgery, but when I was an intern I had to do a term in neurosurgery to get the general surgery rotation I wanted.  The rest is history.

 

What is it about neurosurgery that fascinates you?

A lot of people come into neurosurgery saying, ‘I am really fascinated by neuroscience and the way the brain works’. It is kind of interesting, but I am actually much more fascinated by the people I look after. These are vulnerable people and I am really fascinated by how they respond and cope and be wonderful humans even when everything is going wrong.

You have been a practising neurosurgeon sine 1997. Do any patients stand out?

There are so many. But I will never forget the young woman with brain cancer who, against all odds, felt that she had to have a child despite her limited prognosis. She wanted to leave a legacy and managed to deliver twins between radiation and chemotherapy. She started off with a low grade tumour but ended up a glioblastoma. She was only in her 30s, but fell pregnant while having treatment for cancer.

 

Was falling pregnant against your advice?

Absolutely not.  My job is to make things happen if I can. This is what she desperately wanted and she achieved her goal. She had a girl and a boy and was exhausted, but joyful.

Her twins were just over a year old when she passed away. And then there was the beautiful young couple who postponed their wedding for the brain surgery. They took the wedding photos so you could not notice that one side of his face was drooping. He went through radiation and everything else. Just as they were about to go on their honeymoon, the tumour came back. He started on chemotherapy the night before they got on the plane.  They went all over Europe on chemotherapy so they could still have a honeymoon. These people are extraordinary. I am always inspired by the lives that they make with what they have got. This man lived for maybe 18 months after the wedding.

 

Stage 4 brain cancers are incurable. What do you hope to achieve for your patients?

I want to give them the longest good quality life that we can get. Ultimately, what we hope to achieve is some cure or longer term control. But at the moment, the reality of the job is I help them achieve their goals as best we can.  I think long-term control is within our grasp. We need to translate what we are seeing in immunotherapy to other cancers. It has been disappointing so far, but sometimes it is just one piece of knowledge that drops in, like HER2 inhibitors for breast cancer and Glivec for leukaemia, or BRAF inhibitors and immunotherapy for melanoma.

 

What’s a day in your life like?

I generally start at 6am, so I am up at 5am. I try and get a bit of paperwork done, then hit the wards at 7 am for a ward round. My days are varied: it could be all day in clinic, all day operating, it could be meetings, it could be research. Outside work, I go to movies, I go to plays, I go to the symphony. I read books, I exercise and I hang out with my family. I mostly like superhero movies. I don’t want to watch movies where people are having bad things happen to them. I work with people who have bad things happen every day. I don’t need to see it to have a good cry. I want happy movies.

 

You are now a department head. Where to from here?

Being Head of Unit was kind of my end-game. So now, I think I would like to probably have more influence in brain-tumour research. And I have a real commitment to global health education through my role as Chair of Pangea (formerly Specialists Without Borders). Growing that part of my career portfolio is something that is a real focus at the moment as well.

 

Tell us about Pangea, how it works and your long-term goals for this organisation.

Pangea began 13 years ago, originally as a lecture series in Africa. Basically it involves healthcare professionals from Australia and New Zealand travelling to developing countries to impart some of our knowledge to healthcare professionals working on the ground there.

These people (in developing countries) may be very good doctors, but they are living in a place where there is not very good infrastructure. What Pangea really wants to do is through education, leave behind the expertise to change the health system. We are leaving a sustainable legacy. The lessons we leave behind will benefit health outcomes for their communities for many years. These Australian and New Zealand health professionals pay their own way to do these trips and take annual leave to be part of it all. But it is incredibly rewarding and it is great fun.

My ambition for Pangea is that it becomes a massive organisation. I want it to be the go-to organisation for global medical education needs – providing flexible, practical, scalable, targeted health education in low-resource settings. We have now done several trips to Africa, teaching our counterparts in Malawi, Zimbabwe and Rwanda.

In 2019, we are hoping to go to Myanmar and start educating health professionals in that area to improve outcomes there. The possibilities are endless. Africa we love, but I think we need to have some programs a bit closer to home.

 

What would you say to a young person now contemplating a medical career?

I would say ‘Become a doctor’. It gives you an unlimited range of career possibilities. You might not end up in the clinical care of patients – you could end up in research, administration or international health.  It is a ticket to so many fulfilling careers, in specialty practice or general practice. You don’t have to worry too much about where the end point will be, it is just a great thing to do. You will find your niche.

*November 2018.

 




Breast Cancer Myths

1. All breast cancer patients have the same type of treatment.

Different patients respond differently to treatments, and the sequence and type of treatment should always be tailored to the individual. One person’s treatment plan and experience is very unlikely to be the same as that of a friend, relative or colleague.

There are many different types and degrees of aggression of breast cancer, which are generally distinguished by pathology testing of tissue following surgery. In addition, the diagnosis can occur at different stages (i.e. how large the breast cancer is and much it has spread into nearby or distant tissues). These factors lead to a wide range of different treatment recommendations. Treatment plans for individual breast cancer patients are usually made by the treating team, following multidisciplinary review, to ensure the best co-ordinated treatment program for each patient.

 

2. You can’t go on public transport or eat take-away food while on chemotherapy because of suppressed immunity.

Not all chemotherapy for breast cancer suppress the immune system to the same extent. There are usually short periods (measured in days) during each course of chemotherapy when some patients have a slightly higher risk of developing an infection than normal. Depending on the type of chemotherapy you are receiving, and whether there are other medical conditions that you may also suffer from, the risk of infection is very variable. Common sense will usually guide you as to what situations you should avoid during your chemotherapy treatment. For instance, it is advisable not to sit next to someone who is obviously coughing and unwell, or be in close contact with children who are suffering from a diarrhoeal illness. You do not need to keep yourself isolated from society. Severe dietary restrictions are also unnecessary.

So you CAN go on public transport and eat food which has been prepared hygienically – you can decide if that is the case for the take-away restaurant you go to!

 

3. Needles and blood pressure testing on an arm without lymph nodes cause lymphoedema.

There has been no proven research that demonstrates that lymphoedema is caused by either of these two manoeuvres. A recent study of 632 patients with a total of 3,041 arm measurements showed no increased risk of lymphoedema with blood draws, injections or blood pressure readings. If necessary, you can use your arm without lymph nodes for these purposes, but it is reasonable to avoid this by using the other arm where this is possible. The important aspect to minimise the risk of lymphoedema is to reduce the risk of infections in the arm from which the lymph glands have been removed.

 

4. Rest is best.

This is an old adage if anyone is seriously ill. While there are times when rest does help the body to recuperate after critical periods of illness, the treatment for breast cancer is over a long period, and moderate exercise is actually more beneficial. Exercise can offset fatigue. Strangely, when you are very fatigued and least feel like exercise, a walk can make you feel better. Exercise is also important to maintain good health during treatment and to prevent weight gain.

Weight gain is best avoided as there is good scientific evidence that excessive weight can increase the risk of breast cancer recurrence.

So again, avoiding excessive inactivity is an important step to avoid gaining weight.

 

5. You will feel better as soon as the treatment is finished.

Breast cancer treatment side effects can take some time to resolve completely. The good news is that symptoms such as nausea, vomiting, bowel disturbances, risk of infection and altered taste sensation usually disappear within a few weeks of the last chemotherapy treatment. Hair regrowth usually takes 2 to 4 months to reach the length that a woman may be happy with. Fatigue, in particular, can last for some time, depending on the person. Most people gradually regain the strength and fitness they need to return to their previous lifestyle, so don’t be concerned if it doesn’t happen quickly. Patients need to be patient! Also, if treatment has rendered a woman post-menopausal, time is usually needed for the woman to adjust to the menopause symptoms of hot flushes/sweats, aching joints and frequent fatigue.

 

6. I burn easily in the sun so I will get a radiation burn.

All people react to radiation treatment differently and there are many factors that determine how troublesome the skin reaction will be. These are often technical factors. Skin that has been damaged by the sun over many years reacts differently  to skin that hasn’t been exposed to the sun. Good skin care is important to minimise whatever reaction you will get, and protecting the treated area from sunburn during treatment is important. Your radiation nurse or team members will advise the best skin care for you. Some patients may finish treatment with minimal skin reactions even if they burn easily in the sun.

 

7. You can’t use soap during radiation treatment.

This myth dates back many years to when soaps were very harsh on the skin. For the majority of patients using a mild soap will not be a problem, and your radiation nurse will be in the best position to advise you on your most appropriate skin care. Remember, this advice applies to the area being treated and it’s not necessary to follow the instructions for your entire body.

 

 




STA to market sarcoma drug in Australia, New Zealand and SE Asia Following License Deal

Singapore and Melbourne, Australia, 14 October 2019: Independent pharmaceutical company Specialised Therapeutics Asia (STA) has signed a new license deal, enabling it to provide a global advanced sarcoma therapy to patients in Australia, New Zealand and throughout SE Asia.

Under the terms of the agreement, STA will provide the marine-derived compound YONDELIS (trabectedin) to patients throughout Australia, New Zealand and in South East Asia under exclusive license from Spanish company PharmaMar.

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

Until now, it has not been available in Australia and New Zealand, although it is currently provided to patients in Singapore, Malaysia and Brunei via a previous pharmaceutical arrangement. Former product licensee Janssen will continue to distribute YONDELIS in Singapore, Malaysia and Brunei until marketing authorisation is formally transferred to STA.

Announcing the new deal, STA Chief Executive Officer Mr Carlo Montagner said some Australian patients and their doctors had previously sought to access YONDELIS from international sources, at great difficulty and expense.

“We are delighted to provide this important therapy to patients in Australia, New Zealand and in South-East Asia,” he said.

“We will be immediately seeking approval from the Therapeutic Goods Administration (TGA) and in the interim, will ensure YONDELIS is available to appropriate patients via a Special Access Program.”

Associate Professor Jayesh Desai, Medical Oncologist at the Peter MacCallum Cancer Centre in Melbourne, Australia, and Deputy-Chair of the Australia New Zealand Sarcoma Association (ANZSA) said the availability of YONDELIS in Australia would be greatly appreciated by the sarcoma community.

“Sarcoma is a relatively rare cancer and treatment options are limited for Australian patients with advanced disease,” Associate Professor Desai said.

“YONDELIS has been shown to provide a 45% reduction in the risk of disease progression or death versus dacarbazine in patients who have failed prior therapies,1 and has been a global standard of care. We welcome news that Australian patients will soon be provided access to this therapy that is already providing benefit to sarcoma patients around the world.”

Specialised Therapeutics will now seek formal regulatory approval to market YONDELIS in Australia from the Therapeutic Goods Administration (TGA) and subsequent reimbursement via the Pharmaceutical Benefits Scheme (PBS).

In the interim, a Special Access Program will be opened on November 1 to ensure YONDELIS is available at the earliest opportunity to eligible patients.

PharmaMar President, José María Fernández Sousa-Faro, commented: “This new license arrangement is the third we have struck with STA, and is a strong endorsement of their capabilities in these key marketing regions of Australia, New Zealand and South-East Asia.

“Patients and the medical community will now be provided the opportunity to readily access YONDELIS, which is already recognised as a global standard of care. We look forward to seeing sarcoma patients benefit with improved outcomes.”

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 PFS among the YONDELIS treatment group was 4.2 months (n=345; 95% confidence interval (CI): 3.0 – 4.8 months), while the median PFS in the dacarbazine treatment group was 1.5 months (n=173; 95% CI: 1.5 – 2.6 months), 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 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%), peripheral oedema (24%), dyspnoea (25%) and headache (23%). The most common (≥20%) laboratory abnormalities were neutropenia (49%), increased alanine transaminase (ALT) (45%), thrombocytopaenia (30%), anaemia (39%), increased aspartate aminotransferase (AST) (35%) 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

It is estimated around 1500 new cases of STS will be diagnosed in Australia every year, with more men than women typically affected.6 Median survival from diagnosis has increased from 5.80 years in 1985-1989 to 8.18 years in 2010 – 2014.7The outcome of patients with metastatic disease is poor with a median overall survival (OS) estimated to be between 12 and 18 months.8,9

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.10

  • YONDELIS® (trabectedin) is a globally recognised treatment for patients with advanced soft tissue sarcoma as second-line therapy and beyond, but has been difficult for Australians to access
  • YONDELIS demonstrates 45% reduction in risk of disease progression or death versus dacarbazine1
  • Specialised Therapeutics now filing for TGA approval
  • YONDELIS to be made available in Australia via Special Access Program to open November 1.

 

Further Inquiries

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. Toro JR, et al. Int J Cancer. 2006; 119:2922-2930
  5. 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.
  6. Australian Government. Cancer Australia. Sarcoma statistics in Australia. Available at https://sarcoma.canceraustralia.gov.au/statistics. Last Accessed: October 2019.
  7. Bessen T. et al. Cancer Epidemiology, 2019; 63: 101590
  8. Noujaim J. et al. Indian J Med Paediatr Oncol. 2016; 37(3): 125-130
  9. Dangoor A. et al. Clin Sarcoma Res. 2016; 6:20
  10. Bae S. et al. Clin Sarcoma Res. 2016; 6:11