The results showed sugemalimab plus chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC) demonstrated statistically significant and clinically meaningful benefit in PFS with a well-tolerated safety profile compared to chemotherapy across PD-L1 expression levels and histologies.
Cancer Type: Thoracic tumors
Date:
Presentation Type: Proffered Paper Oral Presentation
Title: LBA-4 GEMSTONE-302: Randomized, Double-Blind, Phase 3 Study of Sugemalimab or Placebo Plus Platinum-Based Chemotherapy as First-Line Treatment for Metastatic NSCLC
Presentation #: 415
Leading PI: Professor Caicun Zhou
GEMSTONE-302 is the first randomized, double-blind, phase III study of anti-PD-L1 monoclonal antibody plus platinum-based chemotherapy as first-line treatment for stage IV squamous or non-squamous non-small cell lung cancer (NSCLC). The study aimed to evaluate the efficacy and safety of sugemalimab combined with chemotherapy vs. placebo combined with chemotherapy in first-line treatment naive patients with stage IV NSCLC. The primary endpoint of the study was investigator-assessed PFS. Secondary endpoints included overall survival, blinded independent central review (BICR)-assessed PFS and safety.
As of
Investigator-assessed median PFS: 7.9 vs 4.9 months, hazard ratio (HR)=0.50 (95% CI: 0.39, 0.64), p
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