FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
Regulatory approval: On Dec 13, 2024, the FDA approved cosibelimab-ipdl (Unloxcyt), a PD-L1–blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. Approval was supported by Study CK-301-101 (NCT03212404), reporting ORR 47% in mCSCC (n=78) and 48% in laCSCC (n=31); median DOR was not reached in mCSCC and was 17.7 months in laCSCC.
FDA approval: cosibelimab-ipdl for advanced CSCC
Type: Regulatory approval
Agency/date: FDA, 2024-12-13
The FDA approved cosibelimab-ipdl (Unloxcyt; Checkpoint Therapeutics, Inc.), a PD-L1–blocking antibody, for adults with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
Supporting evidence
Efficacy and safety were evaluated in Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial in 109 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation. Key exclusions included active/suspected autoimmune disease, allogeneic transplant within 6 months, prior anti–PD-1/PD-L1 or other immune checkpoint inhibitor therapy, uncontrolled/significant cardiovascular disease, ECOG PS ≥2, or HIV/hepatitis B/hepatitis C infection.
Primary efficacy measures: ORR and DOR by independent central review (RECIST v1.1). For laCSCC with externally visible target lesions not assessable radiographically, ORR was determined by digital photography (WHO criteria).
Results: ORR 47% (95% CI, 36–59) in mCSCC (n=78) and 48% (95% CI, 30–67) in laCSCC (n=31). Median DOR was not reached (range 1.4+ to 34.1+) in mCSCC and 17.7 months (range 3.7+ to 17.7) in laCSCC.
Safety and dosing
Most common adverse reactions (≥10%): fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, urinary tract infection.
Recommended dose: 1,200 mg IV over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.