Shots:

• The approval was based on the P-III (KEYNOTE-966) clinical trial evaluating Keytruda (200mg) + CT (gemcitabine, 1,000 mg/m2 & cisplatin, 25 mg/m2) vs PBO + CT, randomized in the ratio 1:1, in patients (n=1,069) with locally advanced unresectable/metastatic biliary tract cancer. In both cohorts, patients received Keytruda + CT or PBO + CT on Day 1 followed by CT alone on Day 8 for Q3W
• The results depicted OS to be 12.7mos. vs 10.9mos with mDOR of 8.3mos. vs. 6.8mos. along with a mPFS of 6.5mos. vs 5.6mos., ORR of 29% vs 29% with CR & PR of 2.1% vs 1.3% & 27% vs 27%
• The safety results of the study demonstrated a difference of ≥5% incidence in adverse reactions between patients in both cohorts for pyrexia (26% vs 20%), rash (21% vs 13%), pruritus (15% vs 10%) and hypothyroidism (9% vs 2.6%)

Ref: Merck | Image: Merck

Related News:- Merck’s P-III Trial Assessing Keytruda Met its Secondary Endpoint in Renal Cell Carcinoma (RCC) Patients

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