- Long-term data show stronger, more durable responses in advanced skin cancer
- First and only PD-L1 inhibitor for aCSCC gains added clinical validation
- Commercial launch in US slated for early 2026
NE BUSINESS BUREAU
MUMBAI, NOV 29
In a major regulatory milestone, Sun Pharmaceutical Industries Ltd has received U.S. FDA approval for an updated label for UNLOXCYT™ (cosibelimab-ipdl), incorporating long-term clinical data that demonstrate improved outcomes in patients with advanced cutaneous squamous cell carcinoma (aCSCC). UNLOXCYT remains the first and only approved PD-L1 immune checkpoint inhibitor for this high-burden skin cancer.
The revised label includes extended results from the pivotal CK-301-101 trial, an open-label, multicenter study of 109 patients with metastatic (mCSCC) or locally advanced disease (laCSCC) who were ineligible for curative surgery or radiation. With longer follow-up, the therapy showed enhanced objective response rates (ORR), with at least 50% of patients achieving a measurable response—marking a notable improvement over earlier analyses. Importantly, the median duration of response (DOR) was not reached in either patient cohort, underscoring the drug’s sustained clinical benefit.
Rapid response times were also observed, with a median onset of 1.9 months in mCSCC and 3.6 months in laCSCC. Across the study, the safety profile remained consistent, with no new immune-mediated adverse reactions, a reassuring outcome for an older patient population often managing multiple comorbidities.
Explaining the broader significance, Richard Ascroft, CEO, Sun Pharma North America, said: “The longer-term results confirm that UNLOXCYT represents an advancement in the available treatment options for people living with aCSCC. More patients responded and maintained their responses than observed in the primary analysis. The updated label reinforces UNLOXCYT as an evolution in checkpoint inhibition.”
UNLOXCYT’s dual-action mechanism—restoring adaptive immunity by blocking PD-L1 interactions and engaging innate immunity via NK-cell–mediated cytotoxicity—has been highlighted as a differentiating strength. The drug also spares PD-L2, potentially reducing off-target immune effects.
Dr. Emily Ruiz, Harvard Medical School, added: “There remains a significant unmet need for therapies that offer durable, long-term efficacy with acceptable tolerability. For many older aCSCC patients, UNLOXCYT provides an important new option that balances both.”
aCSCC remains a major health challenge in the U.S., with nearly 1 million new CSCC cases annually and 40,000 progressing to advanced disease. With FDA approval secured, Sun Pharma plans to commercially launch UNLOXCYT in early 2026, further strengthening its immuno-oncology portfolio while working closely with clinical guideline bodies to broaden access for eligible patients.
