Cosibelimab Earns NCCN Category 2A Designation in Locally Advanced CSCC

Cosibelimab (UNLOXCYT; Sun Pharma) received a National Comprehensive Cancer Network (NCCN) Category 2A preferred designation for patients with locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation, the manufacturer announced October 20, 2026.¹

This is cosibelimab’s second Category 2A designation, following its designation for metastatic CSCC in 2025.

“The elevation of UNLOXCYT to a Category 2A recommendation for patients with [locally advanced] CSCC marks an important milestone, validating the growing body of clinical evidence supporting UNLOXCYT and reflecting increasing confidence among oncology experts in its role as a treatment option for patients with this challenging disease,” Ahmad Naim, MD, senior vice president and North American chief medical officer at Sun Pharma, said in a news release.

Clinical Data Support Cosibelimab’s NCCN Recommendation

The FDA approved cosibelimab for adults with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation, making it the first and only PD-L1-blocking antibody approved for this indication in advanced CSCC.² The recommended dosage is 1200 mg, administered as an intravenous infusion over 60 minutes every 3 weeks.

The decision was based on CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial involving 109 patients with metastatic or locally advanced CSCC who were not candidates for curative surgery or radiation. The objective response rate was 47% (95% CI, 36-59) among patients with metastatic CSCC (n = 78) and 48% (95% CI, 30-67) among those with locally advanced CSCC (n = 31). Median duration of response (DOR) was 17.7 months among patients with locally advanced CSCC, whereas it was not reached among those with metastatic CSCC.

The evidence submitted to NCCN to support the guideline update drew on longer-term follow-up data from CK-301-101.¹ With extended follow-up, responses deepened over time. Among patients with locally advanced CSCC, 55% achieved an objective response, including 26% who achieved a complete response, at a median follow-up of 24.1 months; median DOR was not reached. Across the trial, fewer than 1% of patients experienced a high-grade immune-mediated adverse reaction (imAR).

“This guideline update reflects the strength of the published evidence supporting the use of UNLOXCYT as first-line treatment for [locally advanced] CSCC,” Francis Worden, MD, clinical professor of internal medicine at the University of Michigan Rogel Cancer Center, one of the NCCN member cancer centers, said in a news release. “In the pivotal study, patients experienced durable and clinically meaningful responses. UNLOXCYT also demonstrated a low incidence of high-grade imARs—an important consideration when selecting immune checkpoint inhibitor therapy for a patient population that is mainly elderly and is often afflicted with other health issues.”

NCCN Guidelines Can Shape Coverage and Treatment Access

NCCN is an alliance of 34 leading US cancer centers that provide recommendations for the prevention, diagnosis, evaluation, and treatment of different cancer types. The NCCN Guidelines are among the most influential clinical guidelines in cancer care, offering evidence-based, expert-developed recommendations intended to help clinicians make treatment decisions.

They also have a meaningful impact on patient access, as the guidelines inform payer coverage policies, prior authorization criteria, institutional formularies, and clinical pathways.

“For patients with [locally advanced] CSCC—many of whom are older, medically complex, and vulnerable to treatment-related complications—access to a therapy that offers durable responses together with a low rate of high-grade imARs is especially important,” Mark Gimbert, senior vice president and head of market and patient access, North America, at Sun Pharma, said in a news release. “NCCN recognition helps ensure that appropriate patients can receive this treatment up front without unnecessary access barriers.”

References

1. 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. News release. Sun Pharma. October 20, 2026. Accessed October 21, 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
2. FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma. News release. FDA. December 13, 2024. Accessed October 21, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma