Jazz Pharmaceuticals Advances Combination Therapy for Extensive-Stage Small Cell Lung Cancer

Combination Therapy Success:
Jazz Pharmaceuticals has announced statistically significant improvements in overall survival (OS) and progression-free survival (PFS) for the combination of Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) compared to atezolizumab alone in first-line maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC).

Clinical Trial Details:
The Phase 3 IMforte trial evaluated the efficacy and safety of Zepzelca plus atezolizumab versus atezolizumab alone in adults with ES-SCLC following induction therapy with carboplatin, etoposide, and atezolizumab.

Regulatory Plans:
Jazz plans to submit a supplemental New Drug Application (sNDA) in the first half of 2025 for this combination therapy as a first-line maintenance treatment for ES-SCLC.

Safety Profile:
The combination was generally well-tolerated, with preliminary safety data consistent with the known safety profiles of Zepzelca and atezolizumab, and no new safety signals observed.

Background on Zepzelca:
Zepzelca was approved under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. A confirmatory Phase 3 trial, LAGOON, is ongoing to support full approval in the U.S..