On May 29, 2018 PharmaMar (MSE:PHM) has reported that the Independent Data Monitoring Committee (IDMC) has notified the Company of its recommendation that the Phase III (ATLANTIS) trial currently under way with Zepsyre (lurbinectedin, PM1183) in combination with doxorubicin in small-cell lung cancer patients should continue without any changes (Press release, PharmaMar, MAY 29, 2018, View Source [SID1234527441]).
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The IDMC’s recommendation came after an analysis of the safety data obtained with more than 500 patients treated in the trial. This pivotal randomized Phase III trial assesses the efficacy of PM1183 in combination compared with the standard treatment for this indication: investigator’s choice of either Topotecan or CAV (cyclophosphamide, doxorubicin, and vincristine).
About Zepsyre
Zepsyre (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.
About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%i
About 18% of all the lung
cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded every year. This tumor is strongly associated with tobacco smoking, posing an important public health problemii.
After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.