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Unloxcyt was approved by the FDA as a new treatment for patients with locally advanced or metastatic cutaneous squamous cell carcinoma.
FDA Approves Unloxcyt for patients with locally advanced or metastatic cutaneous squamous cell carcinoma, a type of skin cancer.
The Food and Drug Administration (FDA) has approved Unloxcyt (cosibelimab-ipdl) for patients with locally advanced or metastatic cutaneous squamous cell carcinoma, a type of skin cancer, who are not eligible for curative surgery or curative radiation.
Unloxcyt is a PD-L1-blocking antibody, according to an alert from the FDA. PD-L1-blocking antibodies are types of immune checkpoint inhibitors that help the body destroy cancer cells, as defined by the American Cancer Society.
The efficacy of Unloxcyt was evaluated in the Study CK-301-101 trial, which included 109 patients with locally advanced or metastatic cutaneous squamous cell carcinoma who could not receive curative surgery or curative radiation, the alert stated. Patients were excluded from the trial if they had active or suspected autoimmune disease, an allogeneic stem cell transplant within six months before treatment, received previous treatment with anti-PD-1 or PD-L1 blocking antibodies or other immune checkpoint inhibitor treatment, uncontrolled or significant cardiovascular disease, an ECOG performance status of 2 or higher or an infection with HIV, hepatitis B or C.
ECOG performance status: a measurement of how independently patients can perform everyday tasks. A score of 0 means they can complete tasks independently and a score of 4 means they cannot perform daily tasks independently.
Objective response rate (ORR): percentage of patients who have a complete or partial response to treatment, meaning their tumors disappeared or shrunk.
Duration of response (DOR): time until tumors respond to treatment without worsening or spreading.
Of note, researchers evaluated the objective response rate (ORR) and duration of response (DOR) in the trial. The ORR was 47% in 78 patients with metastatic cutaneous squamous cell carcinoma and 48% in 31 patients with locally advanced cutaneous squamous cell carcinoma, according to the study. The median DOR was not reached in patients with metastatic cutaneous squamous cell carcinoma, meaning not enough people experienced disease worsening on average at the time of data collection. The median DOR was 17.7 months among patients with locally advanced cutaneous squamous cell carcinoma.
Regarding side effects, the most common in 10% or more of patients in the study included fatigue, musculoskeletal pain, rash, diarrhea, constipation, headache, nausea, hypothyroidism, pruritis (itchy skin), edema (fluid retention in body’s tissues), localized infection and urinary tract infection.
The recommended dose of Unloxcyt is 1,200 milligrams, which is given intravenously (through the vein) for one hour every three weeks until disease progression of unacceptable toxicity.
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