drugset / Press release

PharmaMar Reports Update on Phase III LAGOON Trial in Second Line for Small Cell Lung Cancer

2026-06-12 · PharmaMar · original pharmamar.com ↗

PharmaMar (MSE: PHM), announced 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. 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 PopulationLurbinectedin monotherapy Median OSLurbinectedin+ irinotecan Median OSControl Median OSHR (95% CI) Lurbinectedin vs ControlHR (95% CI) Lurbinectedin+irinotecan vs Control Overall8.7 (n=240)10.9 (n=242)10.7 (n=242)1.190 (0.959, 1.476)  0.902 (0.729, 1.115) Without CNS metastases9.6 (n=182)11.1 (n=189)10.7 (n=186)1.106 (0.875, 1.398)  0.922 (0.729, 1.166) With CNS metastases7.1 (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. PharmaMar Call for Investors and Analysts PharmaMar management will host a conference call and webcast for investors and analysts on June 15th, 2026, at 14:00 CEST (08:00 AM, New York time) as follows. The numbers to connect to the teleconference are +1 646 233 4753 (from USA or Canada), +34 91 901 16 44 (from Spain) and +44 20 3936 2999 (other countries). Participants access code: 825412. Interested parties can also follow the conference call live via the following link: https://streamstudio.world-television.com/1052-1618-43506/en The recording of the teleconference will be available for thirty days and it can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com. [1]  RESILIENT all with data since 2018

The release as fetched from its publisher. pharmamar.com ↗