Sun Pharma brings Cosibelimab to U.S. for advanced skin cancer

USA—Sun Pharmaceutical Industries Limited, along with its subsidiaries and associated companies—known as Sun Pharma—has announced the availability of UNLOXCYT™ (cosibelimab-ipdl) in the United States.

Healthcare professionals now prescribe this treatment for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who cannot undergo curative surgery or radiation.

This launch marks a significant step forward for patients facing these challenging forms of skin cancer.

Expert Insights on a New Treatment Option

Ann W. Silk, MD, MS, a medical oncologist at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, commented on the importance of this development.

She explained that patients with unresectable or metastatic CSCC gain a vital new option to manage their disease effectively.

UNLOXCYT, a novel anti-PD-L1 antibody, triggers antibody-dependent cellular cytotoxicity and delivers clinically meaningful results, including a disease control rate of 71%.

Dr. Silk emphasized the therapy’s value for older patients who often deal with multiple comorbidities.

These individuals benefit from a treatment that provides durable disease control alongside proven tolerability.

Because of this balance, UNLOXCYT addresses key needs in a population that requires careful management.

Richard Ascroft, CEO of Sun Pharma North America, added to the discussion by describing UNLOXCYT as an evolution in checkpoint inhibition.

He highlighted how it combines durable efficacy with a strong tolerability profile, which proves especially helpful for advanced CSCC (aCSCC) patients who previously struggled to find such balance.

Sun Pharma has committed to immediate access through the UNLOXCYT SUPPORT™ patient access and affordability program, ensuring that eligible patients receive support from day one.

Updated FDA Approval and Clinical Trial Results

The U.S. Food and Drug Administration (FDA) recently approved an updated label for UNLOXCYT based on long-term follow-up data from the pivotal CK-301-101 clinical trial.

This update reflects improvements in objective response rates, with more patients achieving complete responses (CR).

The study also shows enhanced duration of response, while safety data remains consistent with the original label.

In the trial, many patients experience durable responses with UNLOXCYT. At least 50% achieve an objective response, either complete or partial.

Specifically, 13% of mCSCC patients and 26% of laCSCC patients reach complete response. Overall, 71% of patients secure disease control, including those with stable disease.

Notably, the median duration of response has not yet been reached in either group, signaling long-lasting benefits.

Safety Profile and Common Side Effects

UNLOXCYT carries risks of immune-mediated adverse reactions, which can affect any organ system or tissue and may become severe or fatal, even after treatment ends.

Females use effective contraception during treatment and avoid breastfeeding.

The most common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism.

Immune-mediated adverse reactions primarily rate as Grade 1 or 2.

Only 0.9% qualify as Grade 3, limited to dermatologic issues, and no cases reach Grade 4 or higher.

Of special interest, no patients developed Grade 3 or 4 pneumonitis, whereby just 0.9%—or two patients—experienced Grade 2 pneumonitis.

Understanding Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma ranks among the most common skin cancers worldwide.

While doctors treat early stages successfully, about 40,000 U.S. patients progress to advanced disease each year.

This progression leads to nearly 15,000 deaths annually, underscoring the urgent need for effective therapies like UNLOXCYT.