On December 13, 2024, FDA officials approved cosibelimab-ipdl (Unloxcyt; Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation or metastatic cutaneous squamous cell carcinoma (mCSCC).
Researchers evaluated the PD-L1 blocking antibody’s efficacy in Study CK-301-101 (NCT03212404), which looked at 109 patients who were not not candidates for curative surgery or curative radiation.
For patients with laCSCC with externally visible target lesions not assessable by radiologic imaging, objective response rate (ORR) was determined by committee review assessments of digital photography. The ORR was 47% (95% confidence interval [CI], 36-59) for 78 patients with metastatic CSCC and 48% (95% CI, 30-67) for 31 patients with locally advanced CSCC. Median duration of response was not reached (range, 1.4+ to 34.1+) in patients with metastatic CSCC and was 17.7 months (range, 3.7+ to 17.7) in patients with locally advanced CSCC.
According to an FDA statement, “the most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.”1
Reference
- FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma. Press release. Published December 13, 2024. Accessed December 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma