Lurbinectedin in Patients With SCLC: A Preliminary Safety Analysis From Jazz EMERGE 402

Lurbinectedin monotherapy, which received accelerated approval in the United States for adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy, is currently being studied in Jazz EMERGE 402, a phase 4 trial assessing the real-world effectiveness and safety of lurbinectedin in patients with SCLC. Results from a prespecified preliminary safety analysis of Jazz EMERGE 402 were presented at the 2023 North America Conference on Lung Cancer.

The multicenter trial enrolled patients with SCLC who had received one or more prior platinum-based chemotherapy regimens, with or without IO. The researchers’ analysis included 103 patients enrolled between 2021 and 2022 who received one or more treatment cycles of lurbinectedin. The median patient age was 67 years, 23% had central nervous system involvement, 20% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ³2, and 70% had prior IO. A little more than half, 54%, received lurbinectedin as second-line therapy, and 45% received it as third- or later-line therapy. Granulocyte colony-stimulating factor was given as primary prophylaxis in 28% of patients and as secondary prophylaxis in 6%. The median number of lurbinectedin cycles was three (range, 1-21 cycles), and the median duration of treatment exposure was 81 days (range, 21-457 days). The researchers found that 25 (24%) patients required dose modification, and 17 (17%) required dose reductions. At the time the researchers extracted data, lurbinectedin treatment was ongoing in 37 (36%) patients.

Results showed that treatment-related adverse events (AEs) were reported in 36 (35%) patients, and AEs of special interest were reported in nine (9%), but there were no reported incidences of febrile neutropenia. Among 66 patients who discontinued treatment, the most common reasons were disease progression (56%) and death (14%).

In conclusion, the researchers said, “The real-world safety profile of lurbinectedin was generally consistent with that reported in the basket trial, with no new safety signals identified. Lurbinectedin was well tolerated, with most patients receiving the full dose without dose modifications, and low rates of dose reductions and treatment discontinuation due to AEs.”

Source: Halmos B, Lammers P, Patel M, et al. Real-world use of lurbinectedin in patients with small cell lung cancer: Jazz EMERGE 401 updated analysis. Abstract of a poster presented at the 2023 North America Conference on Lung Cancer; December 1-3, 2023; Chicago, Illinois.