FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC)

Core Insights - Sun Pharmaceutical Industries Limited announced FDA approval for an updated label for UNLOXCYT (cosibelimab-ipdl) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation [1][5][14] - The updated label includes long-term follow-up data from the pivotal CK-301-101 trial, demonstrating durable clinical responses in patients treated with UNLOXCYT [1][6] Efficacy Data - In the CK-301-101 trial, at least 50% of patients achieved the primary endpoint of objective response, with 14% of mCSCC patients and 32% of laCSCC patients achieving stable disease [2][6] - The median duration of response was not reached for either group at the time of follow-up analysis, indicating sustained efficacy [2][6] - The objective response rate (ORR) was 50% for mCSCC and 55% for laCSCC, with complete responses observed in 13% and 26% of patients, respectively [8] Safety Profile - The most common adverse reactions (≥10%) included fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism, with 24% of patients experiencing immune-mediated adverse reactions (imARs) [3][21] - There were no treatment-related deaths reported, and the safety profile remained unchanged with the updated label [6][10] Mechanism of Action - UNLOXCYT works by restoring the adaptive immune response, inhibiting PD-L1 binding to PD-1 on T cells, and engaging the innate immune system through binding to natural killer (NK) cells [4][6] Market Context - CSCC is the second most common type of skin cancer in the U.S., with approximately 1 million diagnoses annually, and around 40,000 cases progress to advanced stages each year [9][10] - UNLOXCYT is the first and only PD-L1 immune checkpoint inhibitor approved for advanced CSCC, addressing a significant unmet need for durable and tolerable treatment options [6][10] Future Plans - Sun Pharma plans to commercially launch UNLOXCYT in early 2026, reinforcing its commitment to advancing innovative treatment options in cutaneous oncology [5][10]