IMforte Shows Benefits of Lurbinectedin/Atezolizumab in ES-SCLC

3D rendered medical illustration of male anatomy with lung cancer: ©Sebastian Kaulitzki - stock.adobe.com

Lurbinectedin (Zepzelca) plus the PD-L1 inhibitor atezolizumab (Tecentriq) led to positive topline results in the phase 3 IMforte study (NCT05091567) vs atezolizumab alone when used as maintenance therapy in extensive-stage small cell lung cancer (ES-SCLC).¹

The combination showed statistically significant improvements in overall survival (OS) and progression-free survival (PFS) as assessed by an independent review facility. Further, the combination was well-tolerated and the safety data observed are in line with the known profiles of the agents. No new signals were observed in the combination arm.

Full data will be presented at an upcoming medical meeting.

"Each year, approximately 30,000 new cases of SCLC are reported in the US. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis, " said Luis Paz-Ares, MD, PhD, head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator, in a press release. "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."

About IMforte

The phase 3 IMforte study has an estimated enrollment of 690 patients across 119 global locations.² Patients with ES-SCLC were randomized 1:1 to receive atezolizumab plus placebo or lurbinectedin as maintenance therapy following induction chemotherapy.

The study’s primary end points are PFS and OS, and secondary end points include objective response rate, duration of response, PFS rates, OS rates, incidence of adverse events, and time to confirmed deterioration.

To be eligible for study participation in the induction phase, patients were required to have an ECOG performance status of 0 or 1, received no prior systemic therapy for ES-SCLC, be treatment-free for at least 6 months for limited-stage SCLC, have adequate hematologic and end-organ function, and have a negative HIV test and no evidence of hepatitis B or C at screening. Those with the presence or history of central nervous system metastases or a history of malignancies other than SCLC within 5 years were not eligible for enrollment.

To continue to the maintenance phase, patients must also have ongoing response or stable disease after 4 cycles of induction therapy, toxicities resolved to at least grade 1, and adequate hematologic and end-organ function.

REFERENCES:

1. Jazz Pharmaceuticals announces statistically significant overall survival and progression-free survival results for Zepzelca® (lurbinectedin) and atezolizumab combination in first-line maintenance therapy for extensive-stage small cell lung cancer. News release. Jazz Pharmaceuticals. October 15, 2024. Accessed October 15, 2024. https://tinyurl.com/4nw4y3a9

2. A phase III, open-label study of maintenance lurbinectedin in combination with atezolizumab compared with atezolizumab in participants with extensive-stage small-cell lung cancer (IMforte). ClinicalTrials.gov. Updated October 8, 2024. Accessed October 15, 2024. https://clinicaltrials.gov/study/NCT05091567