New Delhi: Sun Pharmaceutical Industries Limited has announced that UNLOXCYT (cosibelimab-ipdl) is now available in the United States for prescription by healthcare professionals for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation.
UNLOXCYT is a novel anti–PD-L1 antibody designed to induce antibody-dependent cellular cytotoxicity. The treatment offers a new option for patients with advanced CSCC, a population that often includes older patients with multiple comorbidities and limited therapeutic choices.
“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%,” said Ann W. Silk, MD, MS, medical oncologist at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School.
She added that the therapy’s tolerability profile is particularly valuable for patients who may struggle with more aggressive treatments.
Richard Ascroft, CEO of Sun Pharma North America, said the launch reflects the company’s commitment to access and patient support. “UNLOXCYT is an evolution in checkpoint inhibition, combining durable efficacy with a proven tolerability profile for a group of CSCC 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 program.”
The U.S. 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. The updated data demonstrated improvements in objective response rates, including a higher proportion of complete responses, as well as sustained duration of response. The safety profile remained consistent with the original label.
In the pivotal study, at least 50% of patients achieved an objective response, including complete or partial responses. Complete responses were observed in 13% of patients with mCSCC and 26% of patients with laCSCC. Overall, 71% of patients achieved disease control, including those with stable disease. The median duration of response has not yet been reached in either treatment group.
The most common adverse reactions reported with UNLOXCYT included fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism. Immune-mediated adverse reactions were largely Grade 1 or 2 in severity, with 0.9% of patients experiencing Grade 3 dermatologic reactions and no Grade 4 events reported. Notably, no Grade 3 or 4 pneumonitis cases were observed.
UNLOXCYT is available through a limited distribution network of authorised specialty distributors and a contracted specialty pharmacy. Healthcare professionals can access additional information through the UNLOXCYTPro platform, while patients may receive assistance through the UNLOXCYT SUPPORT programme.
Cutaneous squamous cell carcinoma is among the most common skin cancers globally. While early-stage disease is often treatable, an estimated 40,000 patients in the U.S. progress to advanced stages each year, leading to nearly 15,000 deaths. Major risk factors include chronic ultraviolet exposure and immunosuppression.
UNLOXCYT is indicated for adult patients with mCSCC or laCSCC who are not candidates for curative surgery or radiation and is administered as a 1,200 mg intravenous infusion every three weeks.
