Efficacy, Safety of Lurbinectedin Plus Pembrolizumab for Patients With Relapsed Small Cell Lung Cancer
Results from the Phase 1/2 LUPER Study
Results from the Phase 1/2 LUPER Study
According to results from the phase 1/2 LUPER study, lurbinectedin plus pembrolizumab demonstrated promising efficacy and safety among immunotherapy-naive patients with relapsed small cell lung cancer (SCLC).
In this single-arm, open-label, multicenter study, 28 platinum-sensitive or platinum-resistant (n = 14 each) patients received 3.2 mg/m2 of lurbinectedin plus 200 mg of pembrolizumab once every 3 weeks for up to 35 cycles. The primary end point was investigator-confirmed objective response rate (ORR). Key secondary end points included duration of response, progression-free survival (PFS), overall survival (OS), and safety.
At analysis, the ORR was 46.4% (P < .001) with 3 complete responses and 2 complete metabolic responses at post-treatment completion. The median duration of response was 7.8 months with 40% of patients maintaining response for ≥ 12 months. Median PFS was 4.6 months, and median OS was 10.5 months. Median PFS for platinum-sensitive patients was 8 months and 2.8 months for platinum-resistant patients (P = .012). Median OS was 15.7 months and 7.1 months, respectively (P = .058).
Grade ≥ 3 treatment-related adverse events occurred in 71.4% of patients, with transient neutropenia as the most frequently reported event. The incidence of immune-related adverse events was consistent with prior pembrolizumab results.
“Lurbinectedin plus pembrolizumab showed promising efficacy in relapsed SCLC, particularly for platinum-sensitive patients, with a known and manageable safety profile,” concluded study authors. “These results support further exploration of this combination in SCLC treatment.”
Source:
Calles A, Navarro A, Uribe BGDS, et al. Lurbinectedin plus pembrolizumab in relapsed small cell lung cancer (SCLC): The phase I/II LUPER study. J Thor Oncol. Published online: February 10, 2025. doi: 10.1016/j.jtho.2025.02.005
