Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (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.
Efficacy was evaluated in Study CK-301-101 (ClinicalTrials.gov. Identifier: NCT03212404), a multicenter, multicohort, open-label trial in 109 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation. Patients were excluded if they had any of the following: active or suspected autoimmune disease; allogeneic transplant within six months before treatment; prior treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy; uncontrolled or significant cardiovascular disease; ECOG Performance Status ≥2; or infection with HIV, hepatitis B or hepatitis C.
The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR), as assessed by an independent central review committee (IRC) according to RECIST version 1.1. For patients with laCSCC with externally visible target lesions not assessable by radiological imaging, ORR was determined by IRC assessments of digital photography (WHO criteria). ORR was 47% (95% CI, 36%-59%) for patients with mCSCC (n=78) and 48% (95% CI, 30%-67%) for those with laCSCC (n=31). Median DOR was not reached (range, 1.4+ to 34.1+ months) in patients with mCSCC and 17.7 months (range, 3.7+ to 17.7 months) in patients with laCSCC.
The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection and urinary tract infection.
The full prescribing information for cosibelimab-ipdl is posted here.
Based on a press release from the FDA.
