Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study.

8570Background: SCLC is a deadly cancer and despite initial 80% response, almost all patients (pts) will relapse and die of this disease. Limited options exist after failure of first line, with a median time to progression (TTP) of around 3.5 months. New therapeutic agents are needed. Lurbinectedin (L) is a new anticancer drug that blocks transcription and induces DNA double-strand breaks, leading to apoptosis. Methods: A multicenter phase 2 basket trial to assess the efficacy and safety of L in several types of advanced solid tumors, including SCLC, is ongoing. In the SCLC cohort, 15 adult patients without brain metastases, who had received one prior chemotherapy line, were recruited. If at least one confirmed response was observed, recruitment would be increased to 100 patients. The study intervention comprised L 3.2 mg/m2 in a 1-hour infusion every 3 weeks. Results: 50 pts were treated and evaluable for efficacy. Median age was 60 years (range, 40-83) and 29 (58%) were males. 45 (80%) had an ECOG of 0/...