On October 2, the US Food and Drug Administration (FDA) approved lurbinectedin in combination with atezolizumab, as frontline maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC).1 in patients whose disease had not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide.
The approval was based on efficacy data evaluated from IMforte, a randomized, multicenter, open-label phase III trial in adult patients with treatment-naive ES-SCLC. After completing induction treatment over four cycles, 483 eligible patients were randomized (1:1) to receive maintenance treatment intravenously (IV) every 3 weeks with lurbinectedin plus atezolizumab, or atezolizumab IV alone.2
The primary endpoints were independent review facility-assessed progression-free survival (PFS) and overall survival (OS); all patients were randomly assigned to maintenance phase treatment.
Median OS was 13.2 months (95% confidence interval [CI]: 11.9, 16.4) in the lurbinectedin with atezolizumab arm and 10.6 months (95% CI: 9.5, 12.2) in the atezolizumab arm (hazard ratio [HR] 0.73; 95% CI: 0.57, 0.95; two-sided p-value 0.0174). Median PFS was 5.4 months (95% CI: 4.2, 5.8) and 2.1 months (95% CI: 1.6, 2.7) in the respective arms (HR 0.54; 95% CI: 0.43, 0.67; two-sided p-value <0.0001).1
Resources:
- 1. FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
- 2. Paz-Ares L, Borghaei H, Liu SV, et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025;405(10495):2129-2143. doi:10.1016/S0140-6736(25)01011-6
