Checkpoint Submits BLA to the US FDA for Cosibelimab to Treat Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
Shots:
- 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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