Sun Pharma has received U.S. Food and Drug Administration (FDA) approval for an updated label for UNLOXCYT™ (cosibelimab-ipdl), expanding the information included in its U.S. prescribing guidelines. The update is based on longer-term follow-up data in adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation.
The revised label incorporates results from the CK-301-101 study, a multicenter, multicohort open-label trial involving 109 patients, including 78 with metastatic CSCC and 31 with locally advanced disease.
UNLOXCYT is the first and only PD-L1 immune checkpoint inhibitor approved for advanced CSCC. In the updated analysis, at least half of all treated patients achieved an objective response, with complete and partial responses documented across both trial groups.
Stable disease was also observed in 14% of metastatic cases and 32% of locally advanced cases. Median duration of response had not been reached at the time of analysis, indicating sustained responses over time. Median time to response was 1.9 months in metastatic CSCC and 3.6 months in locally advanced CSCC.
The long-term safety profile remained consistent, with the most common adverse reactions (≥10%) including fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. Immune-mediated adverse reactions occurred in 24% of patients, with high-grade events reported in 0.9%. No treatment-related deaths were observed.
UNLOXCYT functions by blocking PD-L1 from interacting with PD-1 on T cells and B7.1 on antigen-presenting cells, supporting restoration of immune activity. The therapy also uses an Fc domain that engages natural killer cells to promote antibody-dependent cell-mediated cytotoxicity, while sparing PD-L2.
The updated data from CK-301-101 were published in the Journal of the American Academy of Dermatology (JAAD). UNLOXCYT was originally approved in 2024, and Sun Pharma plans a commercial launch tied to the updated label in early 2026.
CSCC is the second most common skin cancer in the United States, affecting about one million people annually. Approximately 40,000 cases progress to an advanced stage each year, and around 15,000 deaths occur. Treatment options for advanced disease remain limited, highlighting the ongoing unmet need in this patient population.
UNLOXCYT is administered as a 1,200 mg intravenous infusion every three weeks and includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications associated with allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
