Unloxcyt Approved for Cutaneous Squamous Cell Carcinoma

Checkpoint Therapeutics announced the US Food and Drug Administration (FDA) approval of Unloxcyt^™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Unloxcyt is the first program death ligand (PD-L1) inhibitor approved for this indication as programmed cell death protein-1 (PD-1) receptor inhibitors like Keytruda^® (pembrolizumab – Merck) have been used for cSCC to date. Clinically meaningful differences for this mechanism of action have yet to be observed. The recommended dose is 1200mg by intravenous (IV) infusion over 60 minutes every three weeks. The launch date isn’t known at this time. For full prescribing information, please click here.

At a Glance

• Brand Drug: Unloxcyt^™ (cosibelimab-ipdl)
• Manufacturer: Checkpoint Therapeutics
• Date Approved: Dec. 13, 2024
• Indication: Treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation
• Dosage Forms Available: 300mg/5mL solution in a single-dose vial
• Launch Date: Launch date is not known at this time.
• Estimated Annual Cost: Cost is not available at this time.
• FDA Designation(s): N/A
• Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Most cases are localized tumors that may be resected, however, about 40,000 cases become advanced and about 15,000 people in the US die each year from cSCC.
• This approval is supported by an open-label trial evaluating Unloxcyt in patients with metastatic and locally advanced cSCC who are not candidates for curative surgery or curative radiation. The metastatic cSCC cohort met its primary endpoint, with Unloxcyt demonstrating a confirmed objective response rate (ORR) of 47.4% (95% CI: 36, 59.1) based on independent central review using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria. The median duration of response (DOR) was not reached but ranged from 1.4 months to 34.1 months. The locally advanced cSCC group had an ORR of 48% (95% CI: 30, 67), and median DOR of 17.7 months.