Jazz Pharmaceuticals announced that the FDA has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®) 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. 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®) updated the NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®) for SCLC to include the Zepzelca and atezolizumab combination as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.
"For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse," said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital. "The Zepzelca and Tecentriq combination provides a new option and a proactive approach in this setting shown to improve progression-free and overall survival in patients who haven't progressed after standard induction chemotherapy with Tecentriq and chemotherapy. The approval may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival."
"ES-SCLC patients have good initial responses but then quickly progress. Extending the time to progression, and ultimately survival, will be clinically valuable, in particular in this fast-moving cancer," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "The introduction of a new maintenance approach offers a new way to manage this aggressive disease and gives patients and their physicians a new treatment option with the potential to increase both PFS and OS. We're proud to advance the standard of care for ES-SCLC and we continue to pursue opportunities in cancer research that improve lives."
The FDA approval is based on results from the Phase 3 IMforte trial (NCT05091567), which showed that the Zepzelca 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 Zepzelca and atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone (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). These results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet.
The most common adverse reactions for Zepzelca in combination with atezolizumab including laboratory abnormalities, (≥ 30%) are decreased lymphocytes, decreased platelets, decreased hemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.
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