harmaMar (MSE:PHM) has announced that the U.S Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide[i]. The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast growing and aggressive cancer with limited treatment options.
The National Comprehensive Cancer Network® (NCCN®) recently updated the NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®) for SCLC to include the combination as preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.
The FDA approval is based on results from the Phase 3 IMforte trial, which showed that 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. Following four cycles of induction therapy, from the point of randomization the median overall survival (OS) for the combination regimen was 13.2 months versus 10.6 months (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). From the point of randomization, median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). Safety was consistent with the known safety profiles of both treatments. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and simultaneously published in The Lancet.
PharmaMar has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), which is currently under review.
[i] ZEPZELCA (lurbinectedin) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.