Friday, Jazz Pharmaceuticals plc (JAZZ) announced that the Phase 3 LAGOON trial, evaluating Zepzelca (lurbinectedin) in patients with relapsed metastatic small cell lung cancer, did not meet its primary endpoint of overall survival.
The trial, conducted by , comprised of three arms: one arm to receive lurbinectedin as monotherapy, the second arm to receive lurbinectedin in combination with irinotecan, and the third arm to receive topotecan or irinotecan based on the investigators' choice.
The data showed a median overall survival of 8.7 months for patients receiving Zepzelca alone and 10.9 months for those treated with the Zepzelca-irinotecan combination. However, neither treatment arm achieved a statistically significant improvement in survival compared with the control group, which recorded a median overall survival of 10.7 months.
Although the study did not meet its primary efficacy endpoint, Zepzelca's safety profile remained consistent with findings from previous clinical studies.
The company has shared these results with the FDA and will discuss next steps with the agency regarding its post-marketing requirements for the Zepzelca second-line indication.
Jazz further assured that the study data will not impact the company's 2026 guidance.
In the pre-market hours, JAZZ is trading at $232.00, down 1.77 percent on the Nasdaq.
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