The US FDA has accepted BLA filing for cosibelimab in patients with metastatic cSCC or LA cSCC who are not candidates for curative surgery or radiation. The US FDA’s decision is expected on January 3, 2024
The submission was based on the registration-enabling clinical trial evaluating cosibelimab. The trial met its 1EPs i.e., the therapy showed a confirmed ORR of 47.4% based on an independent central review in the metastatic cSCC cohort. The results were presented at the ASCO 2022
In the interim results from the LA cSCC cohort, ORR (54.8%) based on independent central review. Cosibelimab is a high affinity, fully-human mAb of IgG1 subtype that binds to PD-L1 & blocks the PD-L1 interaction with the PD-1 and B7.1 receptors
Ref: Checkpoint | Image: Checkpoint
Related News:- Checkpoint Submits BLA to the US FDA for Cosibelimab to Treat Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
