On December 19, 2024 PharmaMar (MSE: PHM) reported that the Phase III LAGOON clinical trial, which evaluates Zepzelca (lurbinectedin) for the treatment of patients with relapsed small cell lung cancer (SCLC), has achieved its recruitment target of 705 patients (Press release, PharmaMar, DEC 19, 2024, View Source [SID1234649219]).
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LAGOON is a randomized (1:1:1), multicenter, open-label Phase III clinical trial with three arms: in the first arm, patients receive lurbinectedin as monotherapy; in the second arm, lurbinectedin is administered in combination with irinotecan; and in the third arm, patients are treated with physician’s choice of topotecan or irinotecan. The study enrolled patients with SCLC whose disease has progressed after one prior line of platinum-based chemotherapy, with or without anti-PD-1 or anti-PD-L1 agents.
The primary objective of the trial is to evaluate overall survival (OS) and progression-free survival (PFS) is one of the secondary endpoints. Top-line results from the study are anticipated in the first quarter of 2026.
Lurbinectedin received accelerated approval from the FDA in June 2020 for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after platinum-based chemotherapy. Since then, it has been approved in 17 territories, including recently in China, although in Europe it has only received approval in Switzerland.
Lurbinectedin is also being investigated in the Phase 3 IMforte clinical trial in combination with atezolizumab compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. As previously announced in October 2024 by Jazz Pharmaceuticals and PharmaMar, the preliminary results from the IMforte trial demonstrated a statistically significant improvement in the primary endpoints of OS and PFS, as assessed by an independent review facility (IRF), for the combination compared to treatment with atezolizumab alone.
SCLC accounts for 15% of all lung cancer diagnoses and is among the most aggressive cancer types. It is characterized by its rapid growth, invasive nature, and early metastasis. Approximately 70% of cases are diagnosed at advanced stages. While the disease often initially responds well to treatment, it tends to recur frequently.