Jazz Pharmaceuticals Provides Update on Zepzelca® (lurbinectedin) Phase 3 LAGOON Trial in Second-Line Small Cell Lung Cancer

Key Points:

• Jazz Pharmaceuticals announced that the Phase 3 LAGOON trial evaluating Zepzelca® (lurbinectedin) for second-line treatment of relapsed metastatic small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival compared to standard therapies.
• The safety profile of Zepzelca, both as monotherapy and combined with irinotecan, was consistent with known data, with no new safety concerns identified.
• Despite the LAGOON trial results, Jazz emphasized that these findings do not impact Zepzelca's U.S. approval or use in the first-line maintenance setting in combination with immunotherapy, based on positive Phase 3 IMforte trial results.
• Jazz will discuss next steps and post-marketing requirements with the FDA regarding the second-line indication and confirmed the LAGOON results do not affect the company's 2026 financial guidance.
• Zepzelca is approved for first-line maintenance treatment of extensive-stage SCLC in combination with atezolizumab and for second-line treatment under accelerated approval, with important safety warnings including risks of myelosuppression, hepatotoxicity, and extravasation.