Jazz Pharma: Zepzelca and Atezolizumab Combo Boosts Survival in First-Line Maintenance for Extensive-Stage Small Cell Lung Cancer

Jazz Pharmaceuticals has shared promising findings from their Phase 3 IMforte trial examining Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance therapy for individuals with extensive-stage small cell lung cancer (ES-SCLC). The trial aimed to assess the efficacy of this combination following initial treatment with carboplatin, etoposide, and atezolizumab. Results revealed marked improvements in both progression-free survival (PFS) and overall survival (OS) when contrasted with the use of atezolizumab alone.

The IMforte trial, recognized as the first global Phase 3 study to show significant benefits in the maintenance treatment of ES-SCLC, has introduced a potential new standard of care. The median PFS for patients receiving the Zepzelca and atezolizumab combination was 5.4 months, compared to 2.1 months for those receiving only atezolizumab. Furthermore, the median OS was 13.2 months for the combination therapy group, outperforming the 10.6 months for the atezolizumab-only group. These results indicate a 46% reduction in the risk of disease progression or death and a 27% reduction in mortality risk for those on the combination therapy.

The IMforte trial findings were unveiled at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and were simultaneously published in The Lancet. The data also supported a supplemental New Drug Application (sNDA) submission to the U.S. Food and Drug Administration (FDA).

Dr. Luis Paz-Ares, the trial's principal investigator, emphasized the aggressive nature of small cell lung cancer, noting that most patients are diagnosed at an advanced stage. He expressed optimism regarding the IMforte trial outcomes, suggesting that the combination therapy could significantly enhance survival rates for patients with a high unmet medical need. In the U.S. alone, approximately 30,000 cases of small cell lung cancer are diagnosed annually, underscoring the importance of these findings.

Dr. Stephen V. Liu, a participant in the trial, highlighted the limited treatment options available for ES-SCLC patients post-induction therapy. He underscored the significance of the combination therapy, which offers a new approach based on solid evidence to improve patient outcomes before disease progression.

Dr. Rob Iannone, Jazz Pharmaceuticals’ executive vice president and chief medical officer, remarked on the trial's implications, noting the potential of Zepzelca combined with atezolizumab to provide a significant clinical benefit as a first-line maintenance treatment for ES-SCLC. He expressed the company's eagerness to work with the FDA to expedite the availability of this therapy to patients.

Safety assessments revealed that the Zepzelca and atezolizumab combination was generally well tolerated, with no unexpected safety issues reported. Adverse events related to treatment were more frequent in the combination therapy group, though serious adverse events were relatively uncommon.

The IMforte trial is a randomized, multicenter study sponsored by Roche and co-funded by Jazz Pharmaceuticals. It evaluates the safety, efficacy, and pharmacokinetics of the Zepzelca and atezolizumab combination against standard first-line maintenance therapy in adults with ES-SCLC who have undergone induction therapy with carboplatin, etoposide, and atezolizumab.

The trial results underscore the potential of this combination therapy, marking a significant advancement in the treatment of ES-SCLC. Jazz Pharmaceuticals anticipates ongoing discussions with regulatory bodies to enhance the availability of this promising treatment option.