FDA Approves Lurbinectedin Plus Atezolizumab for Patients With Extensive-Stage Small Cell Lung Cancer
On October 2, 2025, the United States Food and Drug Administration (FDA) approved lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase for the maintenance treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase, carboplatin, and etoposide.
This approval was based on efficacy data from the IMforte trial. In this multicenter, open-label trial, 483 patients with ES-SCLC who had not progressed after 4 cycles of atezolizumab, carboplatin, and etoposide (induction treatment) were randomized on a 1-to-1 basis to receive either lurbinectedin in combination with atezolizumab administrated intravenously (IV) or atezolizumab IV alone. The major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) as assessed by independent review facility, measured from time to randomization after completion of induction treatment.
The median OS was 13.2 month in the lurbinectedin plus atezolizumab arm vs 10.6 months in the atezolizumab alone arm (2-sided P = .0174). The median PFS was 5.4 months vs 2.1 months, respectively (2-sided P < .0001). The prescribing information for lurbinectedin includes warning and precautions for myelosuppression, hepatotoxicity, extravasation resulting in tissue necrosis, rhabdomyolysis, and embryo-fetal toxicity. The prescribing information for atezolizumab and for atezolizumab with hyaluronidase include warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), and embryo-fetal toxicity.
The recommended dose for lurbinectedin is 3.2 mg/m2 by intravenous infusion every 21 days until disease progression or unacceptable toxicity. The recommended dose for atezolizumab is 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks by intravenous infusion until disease progression or unacceptable toxicity. The recommended dose for atezolizumab plus hyaluronidase is 1875 mg of atezolizumab and 30,000 units of hyaluronidase administered subcutaneously every 3 weeks until disease progression or unacceptable toxicity.
Source:
FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer. Published on October 2, 2025. Accessed October 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive
