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IMforte

Maintenance lurbinectedin plus atezolizumab versus atezolizumab after atezolizumab, carboplatin and etoposide induction in extensive-stage small-cell lung cancer

Phase 3N = 483NCT05091567

Population
Adults with treatment-naive extensive-stage small-cell lung cancer without progression after atezolizumab, carboplatin and etoposide induction
Design
Randomised, open-label phase 3 trial at 96 hospitals in 13 countries. After four 21-day induction cycles of atezolizumab, carboplatin and etoposide (660 enrolled), patients without progression were randomised 1:1 to maintenance lurbinectedin 3.2 mg/m2 plus atezolizumab 1200 mg or atezolizumab 1200 mg every 3 weeks. Co-primary endpoints: independent review facility (IRF)-assessed PFS and OS, measured from randomisation into the maintenance phase. Efficacy was assessed in the full analysis set (all randomised to maintenance).
Primary endpoint
PFS, OS
Arms
  • Lurbinectedin plus atezolizumab (experimental, n = 242): Lurbinectedin 3.2 mg/m2 (with G-CSF prophylaxis) plus atezolizumab 1200 mg every 3 weeks
  • Atezolizumab (control, n = 241): Atezolizumab 1200 mg every 3 weeks
People
Paz-Ares L, IMforte investigators
PFSHR 0.54 (95% CI 0.43–0.67)OSHR 0.73 (95% CI 0.57–0.95)
Show the numbers
Results reported for IMforte
EndpointAnalysisLurbinectedin plus atezolizumabAtezolizumabEffect
PFSFull analysis set (all randomised to maintenance)Independent review facility (IRF) assessment, from randomisation into maintenanceprimaryPaz-Ares 2025——HR 0.54 (95% CI 0.43–0.67)P<0.0001Stratified hazard ratio. The abstract gives no median PFS values.
OSFull analysis set (all randomised to maintenance)From randomisation into the maintenance phaseprimaryPaz-Ares 2025——HR 0.73 (95% CI 0.57–0.95)P=0.017Stratified hazard ratio. Grade 3-4 adverse events 38% (92 of 242) with lurbinectedin plus atezolizumab and 22% (53 of 240) with atezolizumab; grade 5 events 5% (12 of 242) and 3% (6 of 240). The abstract gives no median OS values.
Results reported for IMforte
EndpointAnalysisLurbinectedin plus atezolizumabAtezolizumabEffect
PFSFull analysis set (all randomised to maintenance)Independent review facility (IRF) assessment, from randomisation into maintenanceprimaryPaz-Ares 2025——HR 0.54 (95% CI 0.43–0.67)P<0.0001Stratified hazard ratio. The abstract gives no median PFS values.
OSFull analysis set (all randomised to maintenance)From randomisation into the maintenance phaseprimaryPaz-Ares 2025——HR 0.73 (95% CI 0.57–0.95)P=0.017Stratified hazard ratio. Grade 3-4 adverse events 38% (92 of 242) with lurbinectedin plus atezolizumab and 22% (53 of 240) with atezolizumab; grade 5 events 5% (12 of 242) and 3% (6 of 240). The abstract gives no median OS values.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.540.43–0.67
OS0.730.57–0.95
Primary publication: Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, 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. PubMedDOI

Appears in

Sources

  1. Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, 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.

    PubMedDOI