Pharma Mar : Final data on phase I/II in small-cell lung cancer with Zepsyre® presented at the IASCLC 18th World Conference on Lung Cancer in Japan

• Progression Free Survival benefit observed in the combination of PM1183 and doxorubicin continues to encourage small-cell lung cancer experts

• Presentation selected for "Best of Day" session

As Dr Calvo said "what we have seen is an exceptional Progression Free Survival benefit, and in patients treated with PM1183 in combination with doxorubicin we saw 21 of 27 patients experience some tumor reduction. And this while better managing patient tolerability. In fact, when we look at the toxicities by number of cycles, we can see that they are easily and successfully managed in the day to day life of patients with growth factors and early cycle dose reductions."

This study shows that patients treated with PM1183 in combination with doxorubicin (Phase I/II clinical trial) reached a progression free survival (5.3 months) which compares favorably with historical data of topotecan as a single agent (the PFS varies between 3.1 and 3.5 months). The objective response rate, a 37% is observed in patients in a combination between PM1183 and doxorubicin compares to historical data of topotecan in relapsed disease of between 17% and 24%. In platinum sensitive patients, the progression free survival observed in patients treated with PM1183 in combination with doxorubicin increases up to 6.2 months. With topotecan, historical data in those patients saw a progression free survival ranging from 3.25 to 4.3 months.

This positive data led to the start in August 2016 of the pivotal Phase III ATLANTIS trial to enroll 600 patients over 154 centers in 20 countries and to compare the combination of PM1183 and doxorubicin, versus either Topotecan or CAV (cyclophosphamide, doxorubicin and vincristine).

Zepsyre® 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.

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, PM184 and PM14. 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 www.pharmamar.com.

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