Jazz Pharmaceuticals plc (JAZZ) Tuesday announced positive top-line results from the Phase 3 IMforte study in adults with extensive-stage small cell lung cancer (ES-SCLC).
The study is designed to evaluate Zepzelca in combination with atezolizumab compared to atezolizumab alone for the maintenance treatment for adults with ES-SCLC. Topline data from the study showed that treatment with Zepzelca and atezolizumab combination demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to treatment with atezolizumab alone.
Further, the combination was generally well tolerated. The preliminary safety data in the ongoing trial, which is sponsored by Roche and co-funded by Jazz Pharmaceuticals, was consistent with the known safety profiles of Zepzelca and atezolizumab with no new safety signals observed in the combination arm.
Zepzelca, an approved treatment for metastatic small cell lung cancer (SCLC), is developed by PharmaMar and sold by Jazz in the U.S. Roche's immunotherapy drug atezolizumab is indicated for the treatment of various cancers including NSCLC, SCLC, among others.
Jazz plans to submit supplemental New Drug Application in first half of 2025 for the Zepzelca, atezolizumab combination therapy as a first-line maintenance treatment for ES-SCLC.
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