Shots:

• The registration-enabling clinical trial evaluates cosibelimab (800mg, q2w) in patients with metastatic cSCC
• The study met its 1EPs i.e., the therapy showed a 47.4% ORR based on the independent central review of 78 patients, m-DoR had not yet been reached at the data cut-off point. The safety data from 201 patients with advanced cancers & treated in all cohorts of the ongoing study remained consistent with previously reported studies
• The company is planning to submit a BLA to the US FDA for cosibelimab in 2022, followed by MAA submission in the EU & additional submissions globally. Cosibelimab is a mAb of IgG1 subtype that binds to PD-L1 & blocks PD-L1 interaction with the PD-1 & B7.1 receptors

Ref: Globe Newswire | Image: Checkpoint