The BLA was submitted based on the clinical trial evaluating cosibelimab (800, Q2W & 1200, Q3W) in patients with metastatic (n=78) & locally advanced (n=31) cSCC through the independent central review of patients using the RECIST 1.1 criteria
The results from the study depicted that the 1EPs were met by both cohorts with an ORR of 47.4% & 54.8%. The ORR from the locally advanced cohort exceeded the clinically meaningful lower bound of the 95% two-sided confidence interval of 25%
Cosibelimab is a mAb of IgG1 subtype that inhibits the interaction b/w PD-L1 along with its receptors PD-1 & B7.1 which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response
Ref: Fortressbiotech | Image: Checkpoint
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