Cosibelimab Receives NCCN Category 2A Recommendation for Locally Advanced Cutaneous Squamous Cell Carcinoma
Clinical Summary:
- Guideline Update: The NCCN updated its guidelines to include cosibelimab as a Category 2A recommended option for patients with advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
- Key Outcomes: The recommendation was supported by findings from a trial in which cosibelimab demonstrated an objective response rate of 55%, including complete responses in 26% of patients. Median duration of response was not reached after a median follow-up of 24.1 months, and fewer than 1% of patients experienced grade 3 to 5 immune-mediated adverse reactions.
- Clinical Relevance: This guideline update expands NCCN recognition of cosibelimab for patients with advanced cutaneous squamous cell carcinoma, supporting its use as a treatment option for patients with locally advanced disease who are ineligible for curative surgery or radiation.
The National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to include cosibelimab (Unloxcyt; Sun Pharmaceutical Industries) as a Category 2A recommended treatment option for patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation.
The October 20, 2026, update expands NCCN recognition of cosibelimab, which previously received a Category 2A recommendation for metastatic cSCC in 2025.
The updated NCCN recommendation was supported by findings from the pivotal registration study, which demonstrated an objective response rate (ORR) of 55%, including complete responses in 26% of patients. Responses were durable, with median duration of response not reached at a median follow-up of 24.1 months. The reported duration of response ranged from 8.3 to more than 31.3 months.
Fewer than 1% of patients experienced grade 3 to 5 immune-mediated adverse reactions, with no grade 4 immune-mediated events or deaths reported.
These findings supported the inclusion of cosibelimab as a Category 2A recommended treatment option for patients with locally advanced cSCC who are not candidates for curative surgery or radiation.
Cosibelimab, a PD-L1-blocking antibody, was approved by the US FDA in 2024 for adult patients with locally advanced or metastatic cSCC who are not candidates for curative surgery or radiation.
The recommended dosage of cosibelimab is 1200 mg administered intravenously over 60 minutes every 3 weeks.
The prescribing information includes warnings and precautions for severe and potentially fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
The most commonly reported adverse reactions, occurring in at least 10% of patients, include fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
The guideline update reinforces cosibelimab as a treatment option for patients with advanced cutaneous squamous cell carcinoma, expanding NCCN recognition to include locally advanced disease while maintaining its existing recommendation for metastatic disease.
Source:
PR Newswire. Sun Pharma announces UNLOXCYT® (cosibelimab-ipdl) has received a category 2A preferred designation in the updated NCCN guidelines for locally advanced cutaneous squamous cell carcinoma (laCSCC) patients who are not candidates for curative surgery or curative radiation. Accessed on: October 23, 2026. https://www.prnewswire.com/news-releases/sun-pharma-announces-unloxcyt-cosibelimab-ipdl-has-received-a-category-2a-preferred-designation-in-the-updated-nccn-guidelines-for-locally-advanced-cutaneous-squamous-cell-carcinoma-lacscc-patients-who-are-not-candidates-for--302914405.html
