FDA

Cosibelimab approved for advanced cutaneous squamous cell carcinoma

December 18, 2024

Brand name: Unloxcyt

Generic name: cosibelimab-ipdl

Manufacturer: Checkpoint Therapeutics

Approval date: December 13, 2024

FDA approved Unloxcyt (cosibelimab-ipdl), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who aren’t candidates for curative surgery or curative radiation.

According to a manufacturer press release, Unloxcyt is the first FDA-approved anti-PD-L1 treatment for advanced SCC.

Efficacy

Efficacy was evaluated in Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial involving 109 patients with mCSCC or laCSCC who weren’t candidates for curative surgery or curative radiation. Patients were excluded if they had any of the following: active or suspected autoimmune disease, allogeneic transplant within 6 months prior to treatment, prior treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy, uncontrolled or significant CV disease, ECOG PS ≥2, or infection with HIV, hepatitis B, or hepatitis C.

The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by an independent central review committee (IRC) according to RECIST version 1.1. For patients with laCSCC with externally visible target lesions not assessable by radiologic imaging, ORR was determined by ICR assessments of digital photography (WHO criteria). ORR was 47% (95% CI, 36-59) for patients with mCSCC (n = 78) and 48% (95% CI, 30-67) for patients with laCSCC (n = 31). Median DOR wasn’t reached (range, 1.4+, 34.1+) in patients with mCSCC and 17.7 months (range, 3.7+, 17.7) in patients with laCSCC.

Safety

The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.

Recommended dose

The recommended dose of cosibelimab-ipdl is 1,200 mg administered as an IV infusion over 60 minutes q3wks until disease progression or unacceptable toxicity.

Sources:

FDA. (2024, December 13). FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma. [Press release]. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma

Checkpoint Therapeutics. (2024, December 13). Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT (cosibelimab-ipdl). [Press release]. https://ir.checkpointtx.com/news-events/press-releases/detail/127/checkpoint-therapeutics-announces-fda-approval-of

Checkpoint Therapeutics: Unloxcyt (cosibelimab-ipdl). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf