Sun Pharmaceutical announced UNLOXCYT (cosibelimab-ipdl) is now available in the US for healthcare professionals to prescribe for adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation.

“Patients with unresectable or metastatic CSCC now have a new and important treatment option to manage their disease. UNLOXCYT is a novel anti–PD-L1 antibody that is capable of antibody-dependent cellular cytotoxicity and associated with clinically meaningful efficacy, as shown by a disease control rate of 71 percent. Because these patients tend to be older and have multiple comorbidities, it’s extremely valuable to have a therapy that offers durable disease control and proven tolerability,” said Ann W Silk, MD, MS, Medical Oncologist, Dana-Farber Cancer Institute and Assistant Professor—Medicine, Harvard Medical School.

The US Food and Drug Administration (FDA) recently approved an updated label for UNLOXCYT to reflect long-term follow-up data from the pivotal CK-301-101 clinical trial. This study showed improvements in objective response rates (including more patients who achieved a complete response [CR]) and duration of response. The safety data did not change from the original UNLOXCYT label.

“UNLOXCYT is an evolution in checkpoint inhibition, combining durable efficacy with a proven tolerability profile for a group of aCSCC patients who traditionally would struggle to strike that therapeutic balance. Sun Pharma is committed to ensuring access from day one with the UNLOXCYT SUPPORT patient access and affordability programme,” said Richard Ascroft, CEO, Sun Pharma North America.

Many patients in the pivotal trial experienced durable responses with UNLOXCYT. At least 50 percent demonstrated an objective response (complete or partial response), including 13 percent of mCSCC patients and 26 percent of laCSCC patients who achieved complete response. Seventy one percent of patients achieved disease control with UNLOXCYT, including patients with stable disease. The median duration of response has not yet been reached in either treatment group.

Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, during or after discontinuation of treatment. Females should use effective contraception and avoid breastfeeding during treatment.

The most common Adverse Reactions (ARs) were fatigue, musculoskeletal pain, rash, diarrhoea and hypothyroidism. Immune-mediated adverse reactions (imARs) were primarily Grade 1 or 2; 0.9 percent were Grade 3 (dermatologic only), with no Grade ≥4 imARs.