On October 15, 2024 PharmaMar (MSE: PHM) and its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported positive top-line results from the Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq) 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 (Press release, PharmaMar, OCT 15, 2024, View Source [SID1234647205]). The combination of lurbinectedin and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.
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"Each year, approximately 63,000 to 72,000 new cases of Small Cell Lung Cancer (SCLC) are reported in Europe. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis,[i],[ii],[iii]" said 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. "These trial results demonstrate the efficacy of lurbinectedin, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease."
"The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the lurbinectedin and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting. These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease," 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. "We are pleased with these clinically meaningful results and plan to submit an sNDA in the first half of 2025 to support this combination in the first-line maintenance setting. We thank the investigators and patients who are involved in this trial, along with our partners at Roche."
"Lurbinectedin monotherapy is currently the standard of care in 2L SCLC. In Europe, it is only approved in Switzerland and early access and compassionate use programs have already allowed some European patients to benefit from lurbinectedin," said Javier Jiménez, Chief Medical Officer of PharmaMar.
The combination was generally well-tolerated. The preliminary safety data in the ongoing trial is consistent with the known safety profiles of lurbinectedin and atezolizumab with no new safety signals observed in the combination arm.
Jazz and Roche plan to submit these data for presentation at a future medical meeting.
PharmaMar will submit a marketing authorisation application (MAA) to the EMA in the first half of 2025 to request regulatory approval in the European Union (EU). Lurbinectedin is available for use in 16 territories around the world.