PharmaMar Release: 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
MADRID, October 18, 2017 /PRNewswire/ --
PharmaMar (MCE: PHM), a biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs, has presented updated data from Zepsyre Phase I/II trials in relapse small cell lung cancer in an oral presentation at the International Association for the Study of Lung Cancer (IASLC), at 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan.
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Dr. Emiliano Calvo, Director of the START Madrid Group, and the Director of Clinical Research at START Madrid-CIOCC, Hospital Madrid Norte Sanchinarro, presented final data of the abstract 9249 titled, "Activity and Safety of the Combination of PM 01183 and Doxorubicin in Relapsed SCLC; Final results of a Phase Ib trial."
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).
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