Jazz Pharmaceuticals has announced positive results from the Phase 3 trial of Zepzelca (lurbinectedin) with Roche’s atezolizumab (Tecentriq) when used as maintenance therapy in certain lung cancer patients.
The study evaluated Zepzelca plus PD-L1 inhibitor atezolizumab against atezolizumab alone in adults with extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab.
Nasdaq-listed Jazz Pharmaceuticals plans to submit a supplemental New Drug Application in the first half of 2025.
IMforte is an ongoing Phase 3, randomised, multicentre trial. The primary endpoints are overall survival (OS) and progression-free survival (PFS) assessed by an independent review facility (IRF).
The combination showed a statistically significant improvement in OS and PFS compared to atezolizumab alone.
According to Jazz Pharmaceuticals, the combination of Zepzelca and atezolizumab was generally well-tolerated.
Preliminary safety data from the ongoing trial aligned with the established safety profiles of both drugs. No new safety signals were observed in the combination group.
Jazz Pharmaceuticals chief medical officer and research and development global head and executive vice president Rob Iannone said: “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.
“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 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.”
The US Food and Drug Administration (FDA) granted accelerated approval for Zepzelca in June 2020 to treat adults with metastatic small cell lung cancer (SCLC) after platinum-based chemotherapy.
In December 2021, Jazz and PharmaMar initiated the LAGOON Phase 3 trial to confirm Zepzelca’s benefits in relapsed SCLC, potentially supporting full US approval.
