Sun Pharmaceutical Industries Limited will present long-term efficacy and safety data for its cancer drug UNLOXCYT (cosibelimab-ipdl) at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, on October 24.

 

Thus, highlighting sustained responses and complete tumour responses in patients with advanced cutaneous squamous cell carcinoma (aCSCC).

 

The updated findings from the pivotal CK-301-101 trial cover 205 patients across three study cohorts with locally advanced or metastatic cutaneous squamous cell carcinoma. The results point to durable responses, with complete response rates ranging from 16.7% to 34.4% across the cohorts and an estimated 68.6% to 81.8% of responders remaining in response at two years.

 

UNLOXCYT was approved by the US Food and Drug Administration (FDA) in 2024 for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.

 

The long-term analysis found overall response rates of 51.3% among patients in the first metastatic disease cohort, 53.1% in the locally advanced disease cohort and 44.4% in the second metastatic disease cohort.

 

The strongest complete response result was recorded in the locally advanced cohort, where 34.4% of patients achieved a complete response. Complete response rates in the two metastatic cohorts were 16.7% and 20.6%, respectively.

 

“What is particularly compelling with longer follow-up is not only the durability of response, but also the number of patients who achieved a complete response—a very important outcome for patients living with this disease. 

 

"Together with the consistently low rate of high-grade immune-related adverse events (irAEs), these data reinforce the potential of cosibelimab to provide durable disease control with a manageable safety profile for patients with aCSCC,” said Eva Muñoz-Couselo, Medical Oncology, Vall d’Hebron Hospital & Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and presenting study co-author at ESMO.

 

The study reported a median duration of response of 45.9 months in the first metastatic cohort, which had a median follow-up of 49.9 months. Median duration of response was not reached in the locally advanced cohort, after a median follow-up of 36 months, or in the second metastatic cohort, after 29.9 months of follow-up.

 

Median progression-free survival was 37.3 months in the locally advanced cohort, compared with 7.9 months and 6.1 months in the two metastatic cohorts. Median overall survival was 37.2 months in the first metastatic cohort and had not been reached in the other two groups.

 

The safety profile remained consistent with earlier analyses, with few high-grade immune-related adverse events. Grade 3 immune-related adverse events occurred in 2.9% of patients, with no grade 4 events or immune-related adverse events leading to death.

 

“These data reinforce the potential of cosibelimab in aCSCC, demonstrating consistent responses that persisted over time across cohorts together with a favorable safety profile remained stable with longer follow-up.”

 

“What is particularly notable in these results, is the consistency of the benefit-risk profile over time, with response rates maintained with longer follow-up, an increasing proportion of complete responses, and a substantial majority of responders estimated to remain in response at two years. These findings underscore the potential for cosibelimab-ipdl to deliver clinically meaningful and durable benefit for patients with aCSCC,” said Nikhil Khushalani, Vice Chair for the Department of Cutaneous Oncology at Moffitt Cancer Center and study co-author.

 

“This dataset is one of the largest ever reported prospective studies of aCSCC patients treated with PD-(L)1 monotherapy and provides important clinical context for the potential of UNLOXCYT to deliver durable clinical benefit for patients with aCSCC,” said Ahmad Naim, Senior Vice President, North American Chief Medical Officer, Sun Pharma.

 

“These findings of improvements in clinical response and consistent safety profile of low irAEs over time support the unmet need for patients with aCSCC. And reflects Sun Pharma’s continued commitment to advancing care and providing innovative treatment options that address the needs of patients with difficult-to-treat skin cancers.”