Jazz Pharmaceuticals plans for removal of lurbinectedin (Zepzelca) as second-line metastatic small cell lung cancer. The decision came after the confirmatory Phase 3 Lagoon trial failed on its primary endpoint of overall survival. In this study, Zepzelca monotherapy performed even worse than other chemotherapy regimens. Also, the combination of Zepzelca and irinotexan showed numerical advantage that did not even meet statistical significance.
LAGOON Trial Results in Small Cell Lung Cancer
The open-label LAGOON trial enrolled 724 patients with relapsed SCLC across over 200 sites in the US, Canada and Europe whose disease had progressed after platinum-containing chemotherapy with or without an anti-PD-(L)1 agent. The trail did not meet the primary endpoint point of overall survival for either lurbinectedin arm vs control. In the overall population, the median OS was 8.7 months with lurbinectedin monotherapy vs 11.1 months with lurbinectedin plus irinotecan and 10.7 months with control therapy. The team observed no new safety signals associated with lurbinectedin administrated alone in combination with irinotecan.
FDA Approval History of Zepzelca
FDA had originally granted accelerated approval to lurbinectedin for adults with metastatic small cell lung cancer following disease progression on after platinum-based chemotherapy in June 2020. Additionally, FDA approved lubricant plus atezolizumab as a frontline maintenance regimens for patients with extensive-stage SCLC who have not experienced progression on induction therapy in October 2025. Data showed median OS of 13.2 months vs 10.6 months in lurbinectedin/atezolizumab and atezolizumab monotherapy arms, respectively.
First-Line Maintenance Indication Remains Unaffected
It was also made clear that first-line maintenance indication for lurbinectedin in combination with atezolizumab will not be affected.
Withdrawal Planned for Third Quarter of 2026
In alignment with the FDA, developers plan to submit a labeling supplement to withdraw the second-line indication for lurbinectedin in the third quarter of 2026.
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FAQ
Why is Zepzelca being withdrawn for second-line SCLC?
Jazz Pharmaceuticals plans to withdraw the second-line indication after the Phase 3 LAGOON trial failed to meet its overall survival endpoint.
What did the LAGOON trial find?
The trial found that neither lurbinectedin monotherapy nor lurbinectedin plus irinotecan significantly improved overall survival compared with control therapy.
Will Zepzelca be completely withdrawn?
No. The planned withdrawal applies to its second-line indication. Its first-line maintenance use with atezolizumab will not be affected.
What is Zepzelca used to treat?
Zepzelca, or lurbinectedin, received accelerated FDA approval for adults with metastatic small cell lung cancer whose disease progressed after platinum-based chemotherapy.
When is the Zepzelca withdrawal expected?
Developers plan to submit a labeling supplement to withdraw the second-line indication in the third quarter of 2026.
Does this affect first-line SCLC treatment?
No. The planned withdrawal does not affect the first-line maintenance indication of lurbinectedin in combination with atezolizumab.