Merck announces results from Phase 3 KEYNOTE-966 trial

Merck announced results from the Phase 3 KEYNOTE-966 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy for the first-line treatment of patients with advanced or unresectable biliary tract cancer. Results from the trial showed the KEYTRUDA regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy alone for these patients. After a median follow-up of 25.6 months, KEYTRUDA plus chemotherapy reduced the risk of death by 17% compared to chemotherapy alone for these patients. Median OS was 12.7 months for the KEYTRUDA regimen versus 10.9 months for chemotherapy alone. The one-year OS rate was 52% for the KEYTRUDA regimen versus 44% for chemotherapy alone; the two-year OS rates were 24.9% versus 18.1%, respectively. The OS results were generally consistent across subgroups. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Grade 3-4 treatment-related adverse events occurred in 70% of patients receiving the KEYTRUDA regimen and 69% of patients receiving chemotherapy alone; TRAEs led to death in eight versus three patients, respectively. No new safety signals were identified. Grade 3-4 immune-mediated adverse events occurred in 7% of patients receiving the KEYTRUDA regimen and 4% of patients receiving chemotherapy alone; immune-mediated AEs led to death in one patient receiving the KEYTRUDA regimen.