BeiGene Unveils Results From Late-Stage Tislelizumab In Nasopharyngeal Cancer

BeiGene Ltd BGNE revealed the detailed data from the Phase 3 RATIONALE 309 trial of tislelizumab for nasopharyngeal cancer.

• The trial evaluated tislelizumab versus placebo combined with chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal cancer.
• In August, the National Medical Products Administration of China accepted a supplement application for tislelizumab combined with chemotherapy based on results from the interim analysis of the RATIONALE 309 trial, announced in May.
• As of March 26, with a median follow-up time of 10.0 months, the trial achieved the primary endpoint at the interim analysis. 
• The tislelizumab/chemo combo demonstrated a statistically significant improvement in progression-free survival (PFS) of 9.2 months compared to 7.4 months in the placebo arm. 
• The PFS rate at six, nine, and 12 months was 66.1%, 51.0%, and 35.7% in the treatment arm, compared to 53.0%, 21.6%, and 12.2% in the placebo group.
• The overall response rate (ORR) and complete response (CR) rate were 69.5% and 16.0% for tislelizumab/chemo combo, compared to 55.3% and 6.8% in placebo.
• The safety profile of tislelizumab and chemotherapy combination was manageable, consistent with the known risks of each treatment agent. 
• Price Action: BGNE shares closed at $$305.60 on Thursday.