FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

Regulatory approval: On Oct 2, 2025, the FDA approved lurbinectedin (Zepzelca) with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as maintenance for adults with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction with atezolizumab (or Tecentriq Hybreza), carboplatin, and etoposide. Approval was supported by IMforte (NCT05091567), showing improved OS and PFS versus atezolizumab alone.

FDA approval (Oct 2, 2025): lurbinectedin + atezolizumab-based maintenance in ES-SCLC

The FDA approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction with atezolizumab (or Tecentriq Hybreza), carboplatin, and etoposide.

Supporting trial

Efficacy was evaluated in IMforte (NCT05091567), a randomized, multicenter, open-label trial. 483 patients without progression after 4 cycles of induction atezolizumab/carboplatin/etoposide were randomized 1:1 to:

  • lurbinectedin + atezolizumab (IV), or
  • atezolizumab (IV) alone until progression or unacceptable toxicity.

Major endpoints were overall survival (OS) and progression-free survival (PFS) by IRF per RECIST v1.1 (from post-induction randomization).

  • Median OS: 13.2 vs 10.6 months (HR 0.73; 95% CI 0.57–0.95; p=0.0174)
  • Median PFS: 5.4 vs 2.1 months (HR 0.54; 95% CI 0.43–0.67; p<0.0001)

Safety highlights (label warnings)

Lurbinectedin: myelosuppression, hepatotoxicity, extravasation/tissue necrosis, rhabdomyolysis, embryo-fetal toxicity. Atezolizumab/Tecentriq Hybreza: severe/fatal immune-mediated reactions, infusion reactions, allogeneic HSCT complications, embryo-fetal toxicity.

The review used Project Orbis and received priority review; application reviews are ongoing at partner agencies.

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