Jazz Pharmaceuticals announces ‘positive’ results from Phase 3 IMforte study

Jazz Pharmaceuticals (JAZZ) announced positive results from the Phase 3 IMforte study of Zepzelca in combination with atezolizumab as a first-line maintenance treatment for people with extensive-stage small cell lung cancer, following induction therapy with carboplatin, etoposide and atezolizumab. The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival and overall survival compared to atezolizumab alone. IMforte is the first global Phase 3 trial to demonstrate clinically meaningful PFS and OS benefits in the first-line maintenance setting for ES-SCLC and supports maintenance therapy with Zepzelca plus atezolizumab as a new standard of care for patients. The data were presented today in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago and published simultaneously in The Lancet. Data from the trial served as the basis for the supplemental New Drug Application submission to the U.S. FDA. Following induction therapy with carboplatin, etoposide and atezolizumab, patients who did not have disease progression were randomized to receive Zepzelca plus atezolizumab or atezolizumab alone. From the point of randomization, the median PFS was 5.4 months for the Zepzelca plus atezolizumab combination versus 2.1 months for atezolizumab alone, and median OS was 13.2 months versus 10.6 months. The combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to atezolizumab alone. The Zepzelca plus atezolizumab combination had no new or unexpected safety signals.