Shots:
- The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.)
- Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV over 30 minutes across all adult indications, including both monothx. and combination therapy
- The approval for q6w dosing regimen is based on PK modeling and exposure-response analyses & was supported by an interim analysis of KEYNOTE-555 from a cohort of patients (Cohort B) treated with Keytruda (400mg, q6w). With the approvals, Keytruda has 13 indications across seven tumor types plus MSI-H tumors in Japan
Click here to read full press release/ article | Ref: Merck | Image: Biospace
