Mumbai-based Sun Pharmaceutical Industries Limited has announced that it will present updated long-term clinical data for UNLOXCYT™ (cosibelimab-ipdl) at the upcoming ASCO Annual Meeting in Chicago. The presentation will focus on patients suffering from locally advanced cutaneous squamous cell carcinoma (laCSCC), a serious form of skin cancer.
According to the company, the updated results come from the pivotal CK-301-101 study, which included 64 patients treated with UNLOXCYT. The trial showed an objective response rate of 50%, including complete responses in nearly 27% of patients and partial responses in 23% of patients. Importantly, the median duration of response had not yet been reached even after a median follow-up period of 31 months, indicating durable clinical benefit.
The study population largely reflected real-world clinical settings, with a median patient age of 77 years and nearly two-thirds being male. Patients remained on treatment for a median duration of 60 weeks and received approximately 29 doses during the study period.
Rahul Ladwa, Medical Oncologist at Princess Alexandra Hospital and co-author of the study, stated that the data demonstrate clinically meaningful efficacy with durable responses and a manageable safety profile in this difficult-to-treat patient population.
Sun Pharma also highlighted the favorable safety findings from the trial. Only one patient experienced a Grade 3 or higher immune-related adverse event. The most commonly reported adverse effects included anemia and diarrhea, each observed in 27% of patients. No fatal treatment-related adverse events were reported during the study.
Emily Ruiz, Associate Professor of Dermatology at Harvard Medical School and study co-author, noted that patients with locally advanced cutaneous squamous cell carcinoma are often elderly and have multiple health complications, making effective and tolerable treatment options especially important.
The company said the findings represent results from the second-largest prospective study ever reported in patients with laCSCC treated with PD-(L)1 monotherapy. Sun Pharma plans to present the poster titled “Efficacy and safety of cosibelimab 800 mg every 2 weeks for locally advanced cutaneous squamous cell carcinoma: Updated follow-up from a pivotal study” on May 31, 2026, during the Melanoma/Skin Cancers session at ASCO.
UNLOXCYT is currently approved for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation therapy.
