Sun Pharmaceutical Industries Limited announced the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT? (cosibelimab-ipdl) for the treatment of adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The updated label now incorporates long-term follow-up data from the pivotal CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC), which showed patients receiving UNLOXCYT experienced durable clinical responses.
At least 50% of patients in the trial achieved the primary endpoint of objective response. In addition, 14% of mCSCC patients and 32% of laCSCC patients achieved stable disease. At the time of the follow-up analysis, the median duration of response had not been reached in either group.
Many clinical trial participants achieved a rapid response; median time to response was 1.9 months (range: 1.6-16.9) and 3.6 months (range: 1.7-10.1) in mCSCC and laCSCC, respectively. In the CK-301-101 pivotal trial, the most common adverse reactions (=10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. 53 patients (24%) in this study experienced imARs (any grade), with a low incidence of high-grade events.
Two patients (0.9%) experienced high-grade imARs; both were Grade 3 dermatologic imARs. There were no treatment-related deaths. UNLOXCYT restores the adaptive immune response, enabling T cells to recognize cancer cells by inhibiting the binding of PD-L1 with PD-1 on T cells and B7.1 on antigen-presenting cells.
UNLOXCYT also engages the innate immune system through an active fragment crystallizable (Fc) domain that binds to natural killer (NK) cells to induce antibody-dependent cell-mediated cytotoxicity (ADCC). UNLOXCYT also spares PD-L2, which may help preserve immune tolerance in non-tumor tissues, such as lung and liver, potentially limiting off-target effects and imARs. UNLOXCYT was initially approved by the FDA in 2024.
This updated label approval further underscores Sun Pharma's commitment to advancing data-driven innovation and expanding differentiated immunotherapy treatment options within its growing cutaneous oncology portfolio. With this updated label, Sun Pharma intends to commercially launch UNLOXCYT in early 2026. CSCC is the second most common type of skin cancer in the United States, with approximately 1 million people diagnosed annually.
While most cases are localized tumors amenable to curative resection, each year in the United States approximately 40,000 cases progress to an advanced stage and approximately 15,000 people die of this disease. These patients with advanced-stage disease face limited treatment options and remain a population with a high unmet need. Following the FDA's approval of the UNLOXCYT label, Sun Pharma will continue to focus on ensuring all appropriate patients have access to UNLOXCYT while engaging with pathway and guideline groups, such as the National Comprehensive Cancer Network® (NCCN®),1 to consider this important treatment option for future updates.
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