New Immunotherapy Option for Advanced Skin Cancer

Patients with locally advanced skin cancer now have a preferred treatment option following an NCCN guideline update.

Updated on Oct. 21, 2026 in Cancer

Isometric editorial illustration of a clinical glass vial and centrifuge rotor, representing new medical treatment guidelines for skin cancer. — The National Comprehensive Cancer Network updated its guidelines, naming cosibelimab a preferred immunotherapy for advanced cutaneous squamous cell carcinoma patients. AI Illustration. Upload story photo >

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Does an official medical guideline update increase your trust in a specific cancer treatment protocol?

The National Comprehensive Cancer Network (NCCN) has designated cosibelimab as a preferred treatment option for locally advanced cutaneous squamous cell carcinoma (CSCC) in patients who cannot undergo surgery or radiation. This update follows clinical study data showing durable responses for those living with this skin cancer.

Why it matters

This guideline update provides clinicians and patients with a new, prioritized immunotherapy option for difficult-to-treat skin cancers. It specifically aids individuals who have exhausted standard surgical or radiological interventions.

In the Study CK-301-101 cohort of 31 evaluable patients, cosibelimab achieved an objective response rate of 54.8% and a complete response rate of 25.8%. While results show an estimated 80.2% duration of response at 24 months, the study design was limited by its Phase 1 scope.

The players

NCCN

An alliance of leading cancer centers that develops clinical practice guidelines for oncology care.

Sun Pharma

A pharmaceutical company that manufactures cosibelimab.

University of Michigan Rogel Cancer Center

A comprehensive cancer center that contributed clinical research to the study.

The details

Cosibelimab is an immunotherapy administered intravenously at 800 mg every two weeks. It works by targeting specific immune checkpoints to assist the body's natural defenses in identifying and attacking cancer cells. Researchers measured efficacy using independent central review based on standard RECIST 1.1 criteria to track tumor shrinkage.

2023: Efficacy results published in J Immunother Cancer.
December 2024: FDA approved cosibelimab for locally advanced or metastatic CSCC.
October 20, 2026: NCCN updated clinical practice guidelines for locally advanced CSCC.

Health Landscape

The NCCN Clinical Practice Guidelines serve as the primary framework for oncology standards in the United States. This addition reflects a broader trend of integrating immunotherapy into earlier lines of treatment for locally advanced cutaneous squamous cell carcinoma.

If you or a loved one are facing locally advanced CSCC where surgery or radiation are not options, this designation is a key development to discuss with your oncology team. Ask your physician how this immunotherapy compares to other available treatments for your specific disease stage.

The takeaway

The addition of cosibelimab marks a new prioritized treatment pathway for locally advanced skin cancer. Patients should track any immune-related side effects and report them to their care team immediately, as these occurred in 27.6% of patients in the study.