Madrid - PharmaMar (MSE:PHM) has announced that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received provisional marketing approval for Zepzelca (lurbinectedin) by the Singapore 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 progressed after front line treatment will now have a further therapeutic option.
Lurbinectedin is the first new therapy approved by the HSA to treat second-line SCLC in more than two decades. The Singapore approval follows on from approvals by the US Food and Drug Administration (FDA)2 , as well as the Therapeutic Goods Administration (TGA) in Australia3 .
Lung Cancer Oncologist and past president of Australasian Lung Cancer Trials Group 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, adding that fewer than 5% of these patients currently survived more than five years post diagnosis4,5. 'The new availability of lurbinectedin 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 2 progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes.'
The HSA approval of lurbinectedin has been granted following collaboration with the US FDA via 'Project Orbis' initiative, due to the high unmet clinical need in SCLC. It is based on monotherapy clinical data from the open-label, multi-center, single-arm study in 105 adult patients with SCLC, who had disease progression after treatment with platinum-based chemotherapy.
The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with relapsed SCLC, lurbinectedin provided an Overall Response Rate (ORR) of 35% and a median Duration of Response (DoR) of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC))6.
Lurbinectedin is being made available in Singapore by an independent pharmaceutical company, Specialised Therapeutics, under exclusive license from its 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 diagnoses7,8. 'We are delighted to be able to provide a new therapeutic 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.
PharmaMar president Jose Maria Fernandez, Ph.D., said the Company was delighted Singaporean patients would now be provided access to lurbinectedin. 'We are pleased to bring a new treatment choice to relapsed SCLC patients. The accelerated approval of lurbinectedin underscores its potential to fill an unmet need in this often-overlooked SCLC community.'
About PharmaMar
PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation. PharmaMar has developed and now commercializes Yondelis in Europe by itself, as well as Zepzelca (lurbinectedin), in the US; and Aplidin (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin and PM14. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar also wholly owns other companies: GENOMICA, a molecular diagnostics company; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com
About Specialised Therapeutics
Headquartered in Singapore, Specialised Therapeutics (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.
About lurbinectedin
Lurbinectedin (Zepzelca), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
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PHARMA MAR, S.A. 
