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On December 13, 2024, the Food and Drug Administration sanctioned cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) inhibiting antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are ineligible for curative surgery or radiation therapy.
The efficacy was assessed in Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial involving 109 patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who were ineligible for curative surgery or radiation.
Patients were excluded if they had any of the following conditions: active or suspected autoimmune disease, allogeneic transplant within six months prior to treatment, previous treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitors, uncontrolled or significant cardiovascular disease, ECOG performance status ≥ 2, or infection with HIV, hepatitis B, or hepatitis C.
The primary efficacy outcome measures were objective response rate (ORR) and duration of response (DOR), evaluated by an independent central review committee (IRC) in accordance with RECIST version 1.1. In patients with laCSCC exhibiting externally visible target lesions that cannot be evaluated using radiologic imaging, the overall response rate (ORR) was ascertained via independent central review (ICR) of digital photography according to WHO guidelines. 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).
The median duration of response (DOR) was not attained (range: 1.4+, 34.1+) in patients with metastatic cutaneous squamous cell carcinoma (mCSCC) and was 17.7 months (range: 3.7+, 17.7) in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC).
The predominant adverse responses (≥10%) included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
The advised dosage of cosibelimab-ipilimumab is 1,200 mg, delivered via intravenous infusion for a duration of 60 minutes every three weeks, continuing until disease progression or intolerable toxicity occurs.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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