New Data Shows Jazz Pharma's Zepzelca® & Atezolizumab Combo Boosts Survival in Advanced Lung Cancer

Jazz Pharmaceuticals announced positive top-line results from a Phase 3 clinical trial evaluating Zepzelca® (lurbinectedin) combined with the PD-L1 inhibitor atezolizumab (Tecentriq®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC). The study compared this combination to atezolizumab alone, following induction therapy with carboplatin, etoposide, and atezolizumab. The Zepzelca and atezolizumab combination showed a statistically significant improvement in both overall survival (OS) and progression-free survival (PFS), as evaluated by an independent review facility (IRF), compared to atezolizumab alone. 

Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator, said in a statement, "Each year, approximately 30,000 new cases of small cell lung cancer (SCLC) are reported in the U.S. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis. These trial results demonstrate the efficacy of lurbinectedin, the most widely used agent in second-line SCLC in the United States, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease." 

 Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, commented, "The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the Zepzelca and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting.”

He further continued, “These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease. We are pleased with these clinically meaningful results and plan to submit an NDA in the first half of 2025 to support this combination in the first-line maintenance setting. We thank the investigators and patients involved in this trial, along with our partners at Roche."

The combination treatment showed a favorable tolerance profile, with early safety data from the ongoing trial aligning with the established safety profiles of both Zepzelca and atezolizumab. No new safety concerns emerged with the combination therapy. Jazz and Roche intend to present these findings at an upcoming medical conference.