Sun Pharmaceutical Industries Limited has announced its intention to present updated long-term efficacy and safety data on UNLOXCYT® (cosibelimab-ipdl) at the European Society for Medical Oncology (ESMO) Congress in Madrid on 24 October 2026. The data stems from one of the largest prospective studies conducted in advanced cutaneous squamous cell carcinoma (aCSCC), focusing on both locally advanced and metastatic forms of the disease.
UNLOXCYT®, approved by the U.S. Food and Drug Administration in 2024, is indicated for adults with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation. The drug is the first immune checkpoint inhibitor in aCSCC that aims to restore adaptive immune function while preserving PD-L2 signalling, contributing to its favourable tolerability profile.
The pivotal CK-301-101 trial expanded its analysis to include 205 patients across three advanced CSCC cohorts. The primary endpoint was the objective response rate, with secondary endpoints including duration of response, progression-free survival, overall survival, and safety. The results showed that 34% of patients with locally advanced disease achieved a complete response, while 17%-21% of metastatic patients achieved the same. The safety profile was consistent with earlier analyses, with a low incidence of high-grade immune-related adverse events.
Dr. Eva Muñoz-Couselo, a co-author of the study, highlighted the durability of response and the increasing number of complete responses as key outcomes. She noted that the data reinforces the potential of cosibelimab to provide durable disease control with a manageable safety profile for patients with aCSCC. Dr. Nikhil Khushalani, another study co-author, emphasised the consistency of the benefit-risk profile over time, underscoring the potential for cosibelimab-ipdl to deliver clinically meaningful and durable benefits.
The announcement comes amid growing interest in immunotherapy treatments for skin cancers, particularly those that are difficult to treat. Analysts believe that the consistent safety profile and efficacy results could bolster Sun Pharma’s position in the oncology market. The company continues to explore opportunities to expand access to UNLOXCYT® beyond the U.S., reflecting its commitment to advancing care for skin cancer patients globally.
