The FDA accepted Merck’s Keytruda + Chemo sBLA application for review in Biliary Tract Cancer

CAR-T Digest - August 2020

Jun 08, 2023: Keytruda / Chemo (IV) / Biliary Tract Cancer / Merck: The FDA accepted the sBLA application

The FDA accepted the sBLA application for review based on the positive data from the Phase 3 KEYNOTE-966 trial, looking for the approval of the Keytruda + Chemo combination in BTC
In this trial Keytruda + Chemo demonstrated a statistically significant improvement in overall survival compared to Chemotherapy alone to patients with 1L BTC
As per ASCO 2023 data, HRoL was maintained after the addition of Keytruda to Chemo as a 1L treatment to BTC
- LSM score changes between baseline and week 18 in QLQ-C30 GHS/QoL, PF and RF, QLQ-BIL21 jaundice and pain, and EQ-5D-5L VAS were similar between arms
Time to deterioration was similar between arms
- Median not reached vs 21.2 mo for GHS/QoL
- NR vs 12.0 mo for PF
- 5 mo vs 5.8 mo for RF
- NR vs NR for jaundice
- NR vs NR for pain
70% of patients treated with Keytruda + Chemo had Grade 3 or 4 TRAEs
Together with the efficacy and safety data, these results support Keytruda + Chemo as a new first-line treatment option for advanced BTC