Sun Pharmaceutical Industries’s Unloxcyt Demonstrates 50% Response Rate in Skin Cancer Trial

Summary:
Sun Pharmaceutical Industries announced updated long-term results from the CK-301-101 trial of its skin cancer therapy Unloxcyt, showing durable responses and a manageable safety profile in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC). The study reported a 50 per cent objective response rate among 64 patients, including 27 per cent complete responses, with sustained clinical benefit observed after a median follow-up of 31 months. Researchers highlighted the therapy’s encouraging efficacy and tolerability, while Sun Pharma said the findings reinforce its commitment to advancing treatment options for advanced skin cancer. The updated data will be presented at the ASCO Annual Meeting in Chicago on May 31, 2026. 

Sun Pharmaceutical Industries announced that updated long-term follow-up findings from the pivotal CK-301-101 study of its skin cancer treatment Unloxcyt will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. The study evaluated patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) and demonstrated durable treatment responses along with a manageable safety profile.

The latest investigator-reviewed analysis involved 64 laCSCC patients who received at least one dose of the immunotherapy. The median patient age was 77 years, with men comprising 66 per cent of participants.

Study results showed an objective response rate of 50 per cent, including complete responses in 27 per cent of patients and partial responses in 23 per cent. After a median follow-up period of 31 months, the median duration of response had not yet been reached, suggesting sustained clinical benefit over time. Patients underwent a median of 29 treatment doses across a median therapy duration of 60 weeks.

Rahul Ladwa, medical oncologist at Princess Alexandra Hospital and Greenslopes Private Hospital and co-author of the study, stated that the findings indicate clinically meaningful efficacy, particularly noting the strong rate of complete responses associated with favourable long-term outcomes in laCSCC patients.

The therapy’s safety profile remained largely aligned with earlier findings from a smaller patient group. Immune-related side effects were observed in 34 per cent of patients, while only one patient experienced a Grade 3 or higher immune-related adverse event. Anaemia and diarrhoea were the most frequently reported side effects, each affecting 27 per cent of patients.

Treatment-emergent adverse events occurred in 95 per cent of participants, though no fatal cases were reported. Grade 3 or higher treatment-emergent adverse events were seen in 41 per cent of patients, with 11 per cent considered linked to the treatment.

Emily Ruiz, associate professor of dermatology at Harvard Medical School and study co-author, said the therapy appears to function differently from other checkpoint inhibitors by activating both adaptive and innate immune responses while preserving the PD-1/PD-L2 pathway. She described the findings as encouraging from both efficacy and tolerability perspectives.

Sun Pharma noted that the study represents the second-largest prospective clinical trial involving PD-(L)1 monotherapy for locally advanced cutaneous squamous cell carcinoma. Ahmad Naim, Chief Medical Officer for Sun Pharma North America, said the results reinforce the company’s commitment to advancing treatment options for the skin cancer community and demonstrate durable clinical benefit following more than two and a half years of follow-up.

Unloxcyt is approved for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation treatment. The approved dosage involves intravenous administration of 1,200 mg every three weeks.

Cutaneous squamous cell carcinoma remains one of the most common skin cancers worldwide. According to Sun Pharma, nearly 40,000 patients in the United States progress to advanced disease annually, resulting in approximately 15,000 deaths each year.

The updated study findings are scheduled to be presented during the Melanoma/Skin Cancers poster session at the ASCO Annual Meeting on May 31, 2026.