Cosibelimab OK’d for Cutaneous Squamous Cell Carcinoma

The FDA approved cosibelimab (Unloxcyt) for treating metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults who are not candidates for curative surgery or radiation.

Approval of the new PD-L1 blocking antibody was based on results from CK-301-101, a multicenter, open-label, phase I trial that included 109 patients with metastatic (nodal and/or distant) or locally advanced CSCC not amenable to curative local therapy.

Cosibelimab induced responses in 47% (95% CI 36-59) of the metastatic CSCC patients and 48% (95% CI 30-67) of those with locally advanced CSCC. Median durations of response were not reached in the metastatic group and 17.7 months in the locally advanced group.

“CSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis,” said Emily Ruiz, MD, MPH, of Dana-Farber Cancer Center in Boston, in a press release from cosibelimab’s developer, Checkpoint Therapeutics. “CSCC remains a disease with a significant need for more effective and tolerable treatment options, particularly for patients with concomitant hematological malignancies, solid organ transplant recipients, or a history of autoimmune disorders.”

“Unloxcyt is the first FDA-approved PD-L1-blocking antibody to demonstrate clinically meaningful objective response rates with durable responses in advanced CSCC,” Ruiz continued. “With its dual mechanisms of action and compelling safety profile, this promising drug will provide U.S. oncologists with an important new immunotherapy option for the treatment of CSCC.”

According to Checkpoint Therapeutics, cosibelimab binds to PD-L1 and blocks the interaction between PD-L1 and its T-cell receptors, PD-1 and B7.1.

The most common adverse events with cosibelimab noted in the prescribing information included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

The recommended cosibelimab dose is 1,200 mg administered intravenously every 3 weeks until disease progression or unacceptable toxicity.

Please enable JavaScript to view the comments powered by Disqus.