Public Release: 

New data on PM1183 sees a response rate of 36 percent as single agent in patients with SCLC

Pharmamar

Madrid, September 12th, 2017.- PharmaMar (MSE:PHM) has presented today during the European Society for Medical Oncology congress (ESMO), held in Madrid, positive results of PM1183 (lurbinectedin) in a cohort of 36 patients as monotherapy in patients with advanced and relapsed small-cell lung cancer (SCLC).

The abstract #1529 'Activity of lurbinectedin (PM1183) as single agent and in combination in patients with advanced small cell lung cancer (SCLC)' shows an objective response rate of 36% when PM1183 is used as a single agent.

The results become of special relevance if it taken into account that microcitic lung cancer, also known as small-cell lung cancer, is the most aggressive type of lung cancer for which only one treatment exists, topotecan, approved more than 15 years ago in advanced and relapsed illness. This drug shows a response rate that varies between 17% and 24%.

Dr María Eugenia Olmedo, oncologist at the Ramon y Cajal Universitary Hospital (Madrid, Spain), explains that "PM1183 is a promising compound either in combination or as a single agent in the subtypes of lung cancer, where, for the moment the therapeutic possibilities are scarce and with a limited activity. Especially attractive is the combination with anthracyclines given their well-known activity in this type of cancer, and also with a well-known and manageable toxicity".

As she explains, "70% of patients have metastasis at the moment of diagnosis. Despite this being one of the most sensitive solid tumors to chemo and radio therapy, the response is of a limited duration and the efficacy of the salvage treatment, very poor. This explains the limited survival of these patients and the necessity for new therapies".

The study shows that the relevant adverse events are in their majority hematological, were transitory and manageable thanks to the optimization of the given dose. PM1183 does not produce mucositis, neuropathy or alopecia.

Dr Olmedo has highlighted the small number of progress that exists up to today in small-cell lung cancer. "The therapeutic developments in this illness have been scarce for more than 15 years. For this reason, we need new therapeutic approaches and new compounds that can change the course of this illness that has such a high mortality rate", she concludes.

This abstract also shows the cohort B results reached in the Phase II clinical study of PM1183 in combination with doxorubicin that later resulted in the start of the pivotal Phase III Atlantis trial, currently recruiting patients, and where a progression free survival (PFS) of at least 5.3 months is reached and an objective response of 37% is observed in patients in a combination with doxorubicin. This PFS increases up to 6.2 months in platinum sensitive patients.

Topotecan, as a single agent, shows a progression free survival that varies between 3.3 and 3.5 months. This PFS in platinum sensitive patients is from 3.25 to 4.3 months.

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About PM1183 (lurbinectedin)

PM1183 is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.

About PharmaMar

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyre™ (PM1183), plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.

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