On June 4, 2018 PharmaMar (MSE:PHM) reported new data on the recurrent small-cell lung cancer patients cohort of the phase II basket study with lurbinectedin as a single agent, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, being held from the 1st to the 5th of June in Chicago (Press release, PharmaMar, JUN 4, 2018, View Source [SID1234527118]).

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The multicenter, phase II trial is assessing the safety and efficacy of lurbinectedin in different solid tumors. Among these, small-cell lung cancer, recurrent after one chemotherapy prior line, began by recruiting 15 patients, and later increased to 100 after observing 5 responses in the first 15 patients. The primary endpoint of the study is to measure the overall response rate, also evaluating other secondary objectives such as the duration of response, progression free survival, overall survival, along with the safety profile.

PharmaMar will present the results of the 61 evaluated patients out of the 72 patients recruited so far in the abstract titled "Efficacy and safety of lurbinectedin (PM1183, Zepsyre) in small-cell lung cancer (SCLC): results from a phase 2 study" (abstract#8570). An ORR of 39.3% was seen in these patients.

The median duration of response was 6.2 months and the median overall survival was 12 months.
With respect to the safety profile, the most common adverse event was myelosuppression: 39% of the patients’ registered grade 3/4 neutropenia and 9% had febrile neutropenia. No toxic deaths have been recorded.

"The patients included in this study with small-cell lung cancer are responding favorably to the treatment with lurbinectedin as a single agent. We have observed that this molecule is active in this group of patients, however, we look forward to having more information once recruitment has finalized and we can evaluate all the patients", said Dr. Arturo Soto, Director of Clinical Development at the Oncology Business Unit of PharmaMar.

The studies that will be presented during the congress are available at View Source

About lurbinectedin
Lurbinectedin 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