IMforte Trial: Maintenance With Lurbinectedin Plus Atezolizumab Shows OS, PFS Benefit in ES-SCLC

Lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) showed a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to atezolizumab alone in patients with extensive-stage small cell lung cancer (ES-SCLC), according to top-line phase 3 IMforte trial results announced by Jazz Pharmaceuticals.

The randomized, multicenter clinical trial is evaluating the efficacy, safety, and pharmacokinetics of lurbinectedin plus atezolizumab versus atezolizumab alone as a maintenance treatment for adults with ES-SCLC after induction therapy with carboplatin, etoposide, and atezolizumab. The primary endpoints of the study are OS and PFS, as assessed by an independent review facility.

Luis Paz-Ares, MD, PhD, head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and the principal investigator of the IMforte trial, discussed the topline results and their implications.

“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,” Dr. Paz-Ares said in a statement. “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, MD, MSCE, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, explained that Jazz plans to submit a supplemental New Drug Application (sNDA) for the combination therapy as a first-line maintenance treatment for ES-SCLC.

“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,” Dr. Iannone said in a statement. “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 combination maintenance therapy was “generally well-tolerated” in the IMforte trial and the preliminary safety data in the ongoing trial “was consistent with the known safety profiles of Zepzelca and atezolizumab with no new safety signals observed in the combination arm,” officials said in the announcement.

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals. Jazz and Roche plan to submit these data for presentation at a future medical meeting.

Source: Jazz Pharmaceuticals