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# Jazz Trial Misses Survival Endpoint for Zepzelca in Lung Cancer
- URL: https://www.fdaweb.com/jazz-trial-misses-survival-endpoint-for-zepzelca-in-lung-cancer/
- Published: 2026-06-12T12:00:00.000Z
- Updated: 2026-09-14T13:41:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161302

Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer (SCLC) failed to meet its primary endpoint of overall survival, raising questions about the future of the drug's second-line indication. The global trial, sponsored by Jazz partner PharmaMar, evaluated Zepzelca as both a monotherapy and in combination with irinotecan in patients with metastatic SCLC whose disease had progressed following platinum-based chemotherapy. Neither experimental arm demonstrated a statistically significant overall survival benefit compared with investigator's choice of topotecan or irinotecan, it says.

Median overall survival in the study's intent-to-treat population was 8.7 months for Zepzelca monotherapy, 10.9 months for the Zepzelca-irinotecan combination, and 10.7 months for the control arm, the company says. The results come nearly a year after FDA granted full approval to Zepzelca in the first-line maintenance setting based on the Phase 3 IMforte trial. Jazz emphasized that the LAGOON findings do not affect the drug's approved first-line maintenance indication.

"Relapsed SCLC is an aggressive cancer with a poor prognosis and patients continue to need treatment options, including in later lines of therapy," Jazz executive vice president Rob Iannone is quoted in a release as saying.

Despite the efficacy setback, Jazz reports a favorable safety profile relative to chemotherapy controls. Treatment-related adverse events occurred in 78.5% of patients receiving Zepzelca monotherapy compared with 93.8% in the control arm. Grade 3 or higher treatment-related adverse events were reported in 35% of patients treated with Zepzelca alone, versus 64.4% in the control group.

Zepzelca received accelerated FDA approval in 2020 for adults with metastatic SCLC whose disease progressed on or after platinum-based chemotherapy, based on tumor response and duration of response data.