PharmaMar Presents the Overall Survival Data From the Phase I/II Study of lurbinectedin in Combination With Doxorubicin for Relapsed Small Cell Lung Cancer

MADRID, September 24, 2018 /PRNewswire/ --

• The results are from Cohort B of the Phase I/II Study in patients with relapsed Small Cell Lung Cancer (SCLC). This study preceded the Phase III ATLANTIS study with the same doses and a similar population 
• The poster has been presented at the World Congress of the International Association for the Study of Lung Cancer (IASLC 2018), in Toronto 
• The data reveal an Overall Survival of 10.2 months in patients with SCLC and a chemotherapy free interval (CTFI) of 30 days or longer, reaching 11.5 months in platinum-sensitive patients 
• Safety data, Overall Survival and also Progression Free Survival can be observed on the poster 

PharmaMar (MCE: PHM) has presented data during the International Association for the Study of Lung Cancer (IASLC 2018), that is taking place from the 23^rd to the 26^th of September in Toronto (Canada), on Overall Survival (OS) from the Phase I/II Study of lurbinectedin in combination with doxorubicin for relapsed small cell lung cancer.

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An OS of 10.2 months has been observed in the study for patients treated with lurbinectedin in combination with doxorubicin in patients with a CTFI of 30 days or longer, reaching 11.5 months in platinum-sensitive patients (CTFI- equal or better than 90 days).

We believe that the OS periods observed in this trial are more favorable than those seen in historical trials of the primary treatments used for second line in SCLC, such as topotecan or the CAV combination (cyclophosphamide, adriamycin, vincristine).

This Phase I/II multicenter, clinical study has analyzed the second line treatment of patients with SCLC, corresponding to cohort B (n=27), of the study, involving a doses of 2mg/m^[2] of lurbinectedin + 40mg/m^[2] of doxorubicin, the same doses and similar population to that being evaluated in the randomized Phase III ATLANTIS Study. In July 2018 this study reached its recruitment objective of 600 patients from 160 centers in 20 countries, and the results are expected at the end of 2019.

Dr. Martin Forster, MD, PhD, of the University College London Hospitals and UCL Cancer Institute, UK, has commented, "I have been involved in a wide number of trials with lurbinectedin for more than five years, both in studies as a single agent and in combination, and I think that it is a molecule with a novel mechanism of action and promising anti-cancer activity, which has exhibited acceptable safety profile both as a single agent and in combination. I consider lurbinectedin as an innovative molecule, which I think may have an important role to play in the treatment of patients with this particularly aggressive type of lung cancer, if approved."

Dr. Emiliano Calvo, MD, from the START Madrid-CIOCC Early Phase Clinical Drug Development program, at Hospital Madrid Norte Sanchinarro, Madrid, Spain, has affirmed that, "It is very necessary to have new alternatives for the treatment of this type of aggressive cancer. As we have been able to observe in the Overall Survival data, the combination of lurbinectedin plus doxorubicin appears to show a greater benefit than the current standard treatments, therefore, possibly providing a new therapeutic alternative for the patients that suffer this terrible illness." He adds, "Patients with small cell lung cancer need new therapeutic alternatives, and the results of this lurbinectedin study could help change the landscape of treatment in an environment where, unfortunately, important progress has not been made within the last 15-20 years."

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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 ty-pes 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); and a chemical enterprise, Zelnova Zeltia.

To learn more about PharmaMar, please visit us at http://www.pharmamar.com.

About lurbinectedin 

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.

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SOURCE PharmaMar