Checkpoint Therapeutics’ Unloxcyt (Cosibelimab-ipdl) Receives the US FDA’s Approval for Cutaneous Squamous Cell Carcinoma (cSCC) 

Shots:   

• Checkpoint has received the US FDA’s approval for Unloxcyt (1,200mg, IV, over 60 minutes, Q3W) to treat metastatic or locally advanced cSCC in adults, ineligible for curative surgery or radiation 

• Approval was based on the P-I (CK-301-101) trial in solid tumor patients (incl. cSCC: N=109), showing ORR of 48% with mDoR of 17.7mos. in locally advanced cSCC patients (n=31) & ORR of 47% with mDoR not achieved in metastatic disease patients (n=78) 

• Unloxcyt is a human, anti-PD-L1 IgG1 mAb which blocks the interaction between PD-L1 & T cell receptors (PD-1 & B7.1) producing an anti-tumor immune response 

Ref: Checkpoint Therapeutics | Image: Checkpoint Therapeutics | Press Release

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