(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) reported top-line results from the Phase 3 LAGOON trial, evaluating Zepzelca (lurbinectedin) in patients with relapsed (second-line) metastatic small cell lung cancer (SCLC).
The study, conducted by PharmaMar, did not meet its primary endpoint of overall survival when tested as monotherapy or in combination with irinotecan compared to investigators' choice of topotecan or irinotecan.
Trial Design and Key Results
The LAGOON trial was a randomized, open-label Phase 3 study enrolling patients with extensive-stage SCLC who had progressed after first-line platinum-based chemotherapy. Participants were assigned to receive either Zepzelca alone, Zepzelca plus irinotecan, or investigators' choice of topotecan or irinotecan.
While Zepzelca showed numerical improvements in progression-free survival and response rates, these did not translate into a statistically significant overall survival benefit. Median overall survival was similar across arms, underscoring the difficulty of improving outcomes in relapsed SCLC.
Safety Profile
No new safety signals were observed, and the overall safety profile of Zepzelca alone or in combination remained consistent with prior data.
Executive Commentary
"Relapsed SCLC is an aggressive cancer with a poor prognosis and patients continue to need treatment options," said Rob Iannone, M.D., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. He emphasized that Zepzelca remains an important treatment in SCLC, particularly in the first-line maintenance setting in combination with immunotherapy, based on strong results from the IMforte trial.
Backgroung on Mforte
Zepzelca received full U.S. approval in 2025 following the Phase 3 IMforte trial, which tested Zepzelca in combination with atezolizumab as first-line maintenance treatment for extensive-stage SCLC. The combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to atezolizumab alone.
Next Steps
Jazz has shared the LAGOON results with the FDA and will discuss next steps regarding post-marketing requirements for the Zepzelca second-line indication. Importantly, the outcome does not affect Zepzelca's existing approval in the first-line maintenance setting or the company's 2026 financial guidance.
JAZZ has traded between $105.00 and $243.32 over the past year. The stock closed Thursday's trading at $236.17, up 2.85%. In pre-market trading the stock is at $232.00, down 1.77%.
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