On June 12, 2026 PharmaMar (MSE: PHM), reported top-line results from its Phase III LAGOON trial evaluating Zepzelca (lurbinectedin) in patients with relapsed (second line) metastatic small cell lung cancer (SCLC), which did not meet its primary endpoint of Overall Survival (OS) compared with control arm, nor did the exploratory combination with irinotecan. Safety for lurbinectedin monotherapy is better compared to the control group.

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The LAGOON study targeted a different population in a different setting of SCLC than the IMforte Phase III trial first line maintenance with atezolizumab (Tecentriq) and does not impact lurbinectedin approval in the first-line maintenance setting.

The full European Commission (EC) and U.S. approval of lurbinectedin is based on the Phase III IMforte trial, which evaluated lurbinectedin in combination with atezolizumab as first-line maintenance treatment for patients with extensive-stage SCLC. In the IMforte trial, the lurbinectedin and atezolizumab combination demonstrated a statistically significant improvement in the primary endpoints of OS and progression-free survival (PFS), as assessed by an independent review facility, compared to treatment with atezolizumab alone. The lurbinectedin and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone.

PharmaMar and its partners will share the results with regulatory bodies as needed at appropriate time.

Key Results from the Phase III LAGOON Trial

The LAGOON trial included a broader patient population than the Phase 2 pivotal trial that supported the second-line approval, including patients with a history of CNS involvement.

The outcome of this trial may be impacted by the unexpected OS outperformance of the control arm by 30% (topotecan mOS 10.8) when compared to most recent phase III trials (topotecan 8.3m,)[1] in this setting.

Trial Population Lurbinectedin monotherapy Median OS Lurbinectedin+ irinotecan Median OS Control Median OS HR (95% CI)
Lurbinectedin vs Control HR (95% CI)
Lurbinectedin+irinotecan vs Control
Overall 8.7 (n=240) 10.9 (n=242) 10.7 (n=242) 1.190 (0.959, 1.476) 0.902 (0.729, 1.115)
Without CNS metastases 9.6 (n=182) 11.1 (n=189) 10.7 (n=186) 1.106 (0.875, 1.398) 0.922 (0.729, 1.166)
With CNS metastases 7.1 (n=58) 10.5 (n= 53) 10.3 (n=56) 1.791 (1.162, 2.760) 1.107 (0.724, 1.692)
The overall safety profile for lurbinectedin was favorable relative to the control arm. Treatment-related adverse events (TRAE) were 78.5% with lurbinectedin, 95% with lurbinectedin + irinotecan, and 93.8% with the control arm. TRAEs Grade ≥ 3 were 35% with lurbinectedin, 62.6% with lurbinectedin + irinotecan, and 64.4% with the control arm.

We expect to submit the results to a medical meeting for presentation.

PharmaMar would like to thank all the patients, their families, and the medical staff involved in the study.

(Press release, PharmaMar, JUN 12, 2026, View Source [SID1234666603])