Shots:

• The approval was based on the P-II (KEYNOTE-164) & (KEYNOTE-158) study evaluating Keytruda (200mg, q3w) in 124 & 355 patients with advanced MSI-H or dMMR solid tumors in adults with unresectable or metastatic CRC, EC, GC, small intestine, or BC who have disease progression on or following one prior therapy
• In both studies, Keytruda monothx. showed strong ORR & DoR. In CRC/EC /GC/small intestine/BC, ORR was 34%/51%/37%/56%/41% including a CR rate of 10%/16%/14%/15%/14% & a PR rate of 24%/35%/24%/41%/27% at a median follow-up time of 37.3/21.9/13.9/29.1/19.4mos.
• Additionally, m-OR was not reached, 92% had responses in CRC@3yrs. while 85%/90%/93%/89% @1yr. & 60%/81%/73% & 42% @3yr.

Ref: Merck | Image: Merck