FDA Approves Lurbinectedin and Atezolizumab Combination for Extensive-Stage Small Cell Lung Cancer

On October 2, 2025, the FDA approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide.¹

Efficacy Results

The approval was based on the IMforte trial (NCT05091567), which evaluated 483 patients with ES-SCLC. Median overall survival was 13.2 months with the lurbinectedin-atezolizumab combination, compared with 10.6 months with atezolizumab alone (hazard ratio [HR] 0.73, P=.0174). Median progression-free survival was 5.4 months versus 2.1 months, respectively (HR 0.54, P<.0001).

Safety and Dosage

• Safety Warnings: Lurbinectedin’s prescribing information includes risks of myelosuppression, hepatotoxicity, rhabdomyolysis, and embryo-fetal toxicity. Atezolizumab carries warnings for severe immune-mediated reactions and infusion-related complications.
• Dosage Recommendations:
  • Lurbinectedin: 3.2 mg/m² IV every 21 days
  • Atezolizumab: 840 mg biweekly, 1200 mg triweekly, or 1680 mg every 4 weeks IV
  • Tecentriq Hybreza: 1875 mg atezolizumab with 30,000 units of hyaluronidase subcutaneously every 3 weeks

The approval offers a new maintenance therapy option for ES-SCLC patients following initial response to first-line treatment.

Reference

1. US Food and Drug Administration. FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer. Published October 2023. Accessed October 6, 2023. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizuab-or-atezolizuab-and-hyaluronidase-tqjs-extensive