On October 2, 2025, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq, Genentech) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab-hyaluronidase, carboplatin, and etoposide.
Basis of Approval: IMforte Trial
The approval was based on the randomized, multicenter, open-label phase III IMforte trial (NCT05091567).
- Population: 483 ES-SCLC patients without progression after 4 cycles of atezolizumab, carboplatin, and etoposide induction
- Arms: lurbinectedin + atezolizumab vs atezolizumab alone
- Median OS: 13.2 months vs 10.6 months (HR 0.73, p=0.0174)
- Median PFS: 5.4 months vs 2.1 months (HR 0.54, p<0.0001)
Dosage and Administration
- Lurbinectedin: 3.2 mg/m² IV infusion every 21 days
- Atezolizumab: 840 mg IV q2w, 1200 mg q3w, or 1680 mg q4w
- Atezolizumab + hyaluronidase: 1875 mg + 30,000 units SC q3w
Treatment is continued until disease progression or unacceptable toxicity.
Safety Information
Lurbinectedin labeling includes warnings for myelosuppression, hepatotoxicity, extravasation-related necrosis, rhabdomyolysis, and embryo-fetal toxicity. Atezolizumab warnings include severe/fatal immune-mediated adverse reactions, infusion reactions, HSCT-related complications, and embryo-fetal toxicity.
Regulatory Pathway
This review was conducted under the FDA Oncology Center of Excellence’s Project Orbis with concurrent submissions in Australia, Canada, Israel, and Switzerland. The application was granted priority review and orphan drug designation, and utilized the Assessment Aid to facilitate FDA review.
Conclusion
The approval of lurbinectedin plus atezolizumab provides a new maintenance option for ES-SCLC patients, with demonstrated improvements in OS and PFS. Real-world evidence will be important to further characterize safety and durability.
This article was produced by the Morningglorysciences editorial team.
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