Shots:

• The approval was based on the P-III (IMCgp100-202) trial to evaluate Kimmtrak vs pembrolizumab, ipilimumab, or dacarbazine in a ratio (2:1) in 378 adult patients with mUM. The product is expected to be available in the US within wks.
• In a P-III trial, the patients treated with Kimmtrak showed an OS benefit with m-OS of 22mos., OS in the ITT population (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine), treatment-related adverse reactions were manageable & consistent with the proposed mechanism
• The company has launched a KIMMTRAKConnect program to provide access to patients treated with Kimmtrak  while BLA approval is currently under RTOR program's review with an anticipated PDUFA date of Feb 23, 2022

Ref: Immunocore | Image: Linkedin