Novartis' Tislelizumab Extends Overall Survival In Late-Stage Esophageal Cancer Study

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  • Novartis AG NVS announced results from the Phase 3 RATIONALE 306 trial of tislelizumab plus chemotherapy in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
  • The data showed that the tislelizumab / chemo combo significantly improved overall survival (OS) as a first-line treatment, regardless of PD-L1 status versus chemotherapy.
  • Tislelizumab combo demonstrated a median OS of 17.2 months versus 10.6 months in patients receiving chemotherapy plus placebo and reduced the risk of death by 34%.
  • Read NextFDA Approves Novartis' Tafinlar + Mekinist Broadening BRAF/MEK Cancer Combo Use.
  • In patients with a PD-L1 score ≥10% (secondary endpoint), tislelizumab plus chemotherapy showed a median OS of 16.6 months versus 10.0 months and reduced the risk of death by 38%.
  • Tislelizumab plus chemotherapy also significantly improved progression-free survival (7.3 months vs. 5.6 months) and objective response rate (63.5% vs. 42.4%) 
  • The incidence of treatment-related adverse events (TRAEs) was similar in both arms. The most common TRAEs for tislelizumab plus chemotherapy were anemia, decreased neutrophils, white blood cell count & appetite, nausea, and peripheral sensory neuropathy.
  • In January 2021BeiGene Ltd BGNE collaborated with Novartis for the clinical development and marketing of tislelizumab in North America, Europe, and Japan.
  • Price Action: NVS shares are down 0.97% at $83.95 during the premarket session on the last check Thursday.
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