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Benzinga
Benzinga
Technology
Vandana Singh

Novartis - BeiGene's Tislelizumab Aces Late-Stage Esophageal Cancer Trial

Novartis Chemotherapy Cancer BGNE EMA NVS European Medicines Agency FDA Nasdaq Novartis AG
  • Novartis AG (NYSE:NVS) has announced topline results from an interim analysis of the Phase 3 RATIONALE 306 study of tislelizumab plus chemotherapy in esophageal squamous cell carcinoma (ESCC).
  • Data showed that tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic ESCC, regardless of PD-L1 expression. 
  • Novartis intends to submit these data to regulatory authorities and collaborate with BeiGene Ltd (NASDAQ:BGNE) to present them at an upcoming medical meeting.
  • Tislelizumab is currently under review by the FDA and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. 
  • The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.
  • Price Action: NVS shares are up 0.03% at $88.99, and BGNE shares are up 6.42% at $162.37 during the market session on the last check Wednesday.
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