Checkpoint Therapeutics Reports New Results from Pivotal Studies of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma
Shots:
- The new, longer-term data from its pivotal studies evaluating cosibelimab, showed a deepening of response over time with higher CR rates than previously reported, responses remain durable over time
- As of data cutoff of Jan 2023 in LA & metastatic cSCC, ORR (55% & 50%); CR rate (23% & 13%), PR rate (32% & 37%), responses ongoing (82% & 69%) & m-DoR (not reached). Updated safety data across 247 patients in all cohorts of the ongoing study remain consistent with prior reported, sev. irAE (2%) & ≤1% discontinued treatment due to an irAE of any severity
- The company submitted a BLA to the US FDA seeking approval of cosibelimab in Jan 2023 for metastatic cSCC or LA cSCC and is currently under review with an expected PDUFA of Jan 2024
Ref: Globenewswire | Image: Checkpoint
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