Lurbinectedin (PM01183) with doxorubicin (DOX), an active treatment as second-line therapy in small cell lung cancer (SCLC).

7509 Background: PM01183 inhibits transactivated transcription and acts on the tumor microenvironment. It lacks cross-resistance with platinum. PM01183 and DOX are synergistic in vitro. Recommended dose (RD): 4 mg (or 2 mg/m2) + 50 mg/m2, respectively, both on day (D) 1 every 3 weeks. Compelling activity was observed earlier in 2nd line SCLC patients (pts), leading to a cohort expansion. The historical response rate (RR) of DOX-based combinations is around 20%. Methods: SCLC pts ≤ 75 years with ECOG PS 0-1, adequate organ function and 1 prior chemotherapy-containing line were included. Stable asymptomatic brain metastases were allowed. DOX was discontinued before reaching 450 mg/m2, non-progressing pts could continue on PM01183 alone. CSF prophylaxis was not mandatory. Results: 21 pts were treated and evaluable for efficacy [response rate (RR) by RECIST v1.1]. Male: 76%; median age: 62 y (r, 48-73); ECOG PS = 0/1 in 43%/57%; 29% had brain metastases, 62% had bulky disease and 81% responded to 1st line, 5%...