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2h ago

FDA Approves Lurbinectedin Plus Atezolizumab as First-Line Maintenance for Extensive-Stage SCLC

The decision follows IMforte data showing clinically meaningful survival gains over atezolizumab alone.

Dr Sabari on the FDA Approval of Maintenance Lurbinectedin Plus Atezolizumab for ES-SCLC | OncLive
FDA Approval Insights: Maintenance Lurbinectedin Plus Atezolizumab for ES-SCLC: With Anne Chiang, MD, PhD; and Stephen Liu, MD

Overview

  • Adults with extensive-stage small cell lung cancer whose disease has not progressed after induction are now eligible for maintenance lurbinectedin with atezolizumab or the hyaluronidase formulation.
  • In IMforte, median progression-free survival reached 5.4 months with the combination versus 2.1 months with atezolizumab alone (HR 0.54; P < .0001).
  • Median overall survival improved to 13.2 months with the combination compared with 10.6 months on monotherapy (HR 0.73; P = .0174).
  • Safety analysis showed higher adverse event rates with the combination, including more nausea, anemia, neutropenia, and thrombocytopenia, with any-grade events in 97.1% versus 80.8%.
  • Experts described the approval as practice-changing and urged careful selection of fit patients with adequate hematologic recovery, noting IMforte’s no-crossover design and PD‑L1–only maintenance as the prior norm.