FDA approves Unloxcyt for advanced cutaneous squamous cell carcinoma
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Key takeaways:
- The indication applies to adults with metastatic or locally advanced disease who are not candidates for curative surgery or radiation.
- Nearly half of those who received the agent in a study responded to therapy.
The FDA approved cosibelimab-ipdl for the treatment of certain patients with cutaneous squamous cell carcinoma.
The indication applies to adults with metastatic or locally advanced disease who are not candidates for curative surgery or curative radiation.
Cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics) is an anti-PD-1 antibody.
The FDA based approval on results of the multicenter Study CK-301-101, which included 109 patients with metastatic (n = 78) or locally advanced (n = 31) cutaneous squamous cell carcinoma deemed unsuitable candidates for curative treatment with surgery or radiation.
Study protocol excluded patients with active or suspected autoimmune disease; those who underwent allogeneic transplant within the prior 6 months; those who received prior anti-PD-1/PD-1 antibodies or other checkpoint inhibitors; those with uncontrolled or significant cardiovascular disease; anyone with ECOG performance status of 2 or higher; or those who had HIV, hepatitis B or hepatitis C infection.
Objective response rate and duration of response per independent central review committee assessment served as the primary efficacy outcomes.
Results showed ORRs of 47% (95% CI; 36-59) among those with metastatic disease and 48% (95% CI; 30-67) among those with locally advanced disease.
Median duration of response had not been reached (95% CI, 1.4+ to 34.1+) among those with metastatic disease and reached 17.7 months (95% CI, 3.7+ to 17.7) among those with locally advanced disease.
The most common adverse reactions included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection and urinary tract infection, according to an FDA press release.
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