Shots:
The company reported the interim efficacy result from its registration-enabling clinical trial evaluating cosibelimab in patients with LA cSCC who are not candidates for curative surgery or radiation
As of the Mar 2022 data cutoff, the therapy showed an ORR of 54.8% as determined by ICR in 31 patients, exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval by 25%
Cosibelimab is a fully-human mAb of IgG1 subtype that binds to PD-L1 and inhibits its interaction with the PD-1 and B7.1 receptors. The company plans to continue discussions with the US FDA about adding LA cSCC as a second indication with an expected BLA submission in 2022
Ref: Globe Newswire | Image: Checkpoint
