Jazz Pharmaceuticals reported that the Phase 3 LAGOON trial evaluating Zepzelca (lurbinectedin) in relapsed (second-line) metastatic small cell lung cancer did not meet its primary endpoint of overall survival. The study, conducted by partner PharmaMar, compared Zepzelca given as monotherapy or in combination with irinotecan against investigators’ choice of topotecan or irinotecan and failed to show a survival benefit for the experimental arms. No new safety signals were identified with Zepzelca alone or in combination with irinotecan, and the safety profiles were consistent with the known profiles of each agent.
Company leadership emphasized that relapsed SCLC remains an aggressive cancer with poor prognosis and a continued need for treatment options, particularly in later lines of therapy. Jazz reiterated its view that Zepzelca’s greatest value lies in the first-line maintenance setting in combination with immunotherapy, citing positive results from the Phase 3 IMforte trial in extensive-stage SCLC. In IMforte, Zepzelca plus atezolizumab as first-line maintenance therapy demonstrated statistically significant improvements in overall survival and progression-free survival versus atezolizumab alone, reducing the risk of disease progression or death by 46% and the risk of death by 27%. These IMforte data supported Zepzelca’s full U.S. approval in 2025 in the first-line maintenance setting, and Jazz stressed that the LAGOON findings do not affect that indication.
Jazz has shared the LAGOON results with the U.S. Food and Drug Administration and plans to discuss next steps with the agency regarding post-marketing requirements tied to Zepzelca’s second-line indication.
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