Merck Presents P-III Trial (KEYNOTE-966) Results of Keytruda for Advanced or Unresectable Biliary Tract Cancer at AACR 2023 Published in The Lancet
- The P-III trial evaluating Keytruda (200mg, q3w for ~2yrs.) + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 1069 patients
- The results showed an improvement in OS, a 17% reduction in risk of death after a median follow-up of 25.6mos., m-OS was 12.7mos. vs 10.9mos., 1 & 2 yr. OS rate was 52% & 24.9% vs 44% vs 18.1%, respectively. The OS results were consistent across subgroups & the results are being shared with regulatory authorities globally
- The safety profile was consistent with prior reported studies, grade 3-4 TRAEs (70% vs 69%); TRAEs led to death (2% vs 1%) with no new safety signals, grade 3-4 immune-mediated AEs (7% vs 4%); patient experienced immune-mediated AEs that resulted in death (1%)
Ref: BusinessWire | Image: Merck
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