BeiGene's Tislelizumab Shows Non-Inferiority In Overall Survival, Safety Vs Standard Treatment In Solid Tumors

  • BeiGene Limited BGNE shared updates from its solid tumor development program for tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.
  • The Phase 3 RATIONALE 301 trial of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma met its primary endpoint of overall survival (OS) non-inferiority.
  • The median OS was 15.9 months for tislelizumab compared to 14.1 months for Bayer AG BAYRY Nexavar (sorafenib).
  • Related: BeiGene's Inspections Delay Suggest Eventual Approval, Says This Analyst.
  • Superiority was subsequently tested, which was not met.
  • In the RATIONALE 301 trial, tislelizumab was associated with a higher objective response rate (ORR) (14.3% vs. 5.4%) and more durable responses (median duration of response (DoR) 36.1 months vs. 11.0 months) compared with sorafenib. 
  • Median progression-free survival (PFS) for tislelizumab versus sorafenib was 2.1 months vs. 3.4 months respectively; HR: 1.11 [95% CI: 0.92, 1.33].
  • The safety profiles for tislelizumab and sorafenib treatments were consistent with previous studies, and tislelizumab demonstrated a comparatively favorable profile versus sorafenib with lower incidence rates of grade >3 adverse events.
  • Price Action: BGNE shares closed at $170.71 on Friday.
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