PharmaMar has announced positive results from the Phase 3 IMforte study of Zepzelca®? (lurbinectedin) in combination with atezolizumab (Tecentriq®?) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab. The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) 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 lurbinectedin plus atezolizumab as a new standard of care for patients. The data were presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and published simultaneously in The Lancet. Data from the trial served as the basis for the supplemental New Drug Application (sNDA) submission to the FDA by Jazz Pharmaceuticals, as well as for the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by PharmaMar.
Following induction therapy with carboplatin Inc., etoposide and Atezolizumab, patients who did not have disease progression were randomized to receive lurbinectedin plus Atezolizumab or atezolizumab in the maintenance phase. The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals.
