Press Release Overview

Sun Pharmaceutical Industries Limited announced it will present long-term follow-up data on UNLOXCYT® (cosibelimab-ipdl) at the European Society for Medical Oncology (ESMO) Congress on October 24, 2026 in Madrid, Spain. The data comes from one of the largest prospective studies in advanced Cutaneous Squamous Cell Carcinoma (aCSCC).

Product Background

UNLOXCYT was approved by the U.S. Food and Drug Administration (FDA) in 2024 and is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The recommended dosage is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.

UNLOXCYT is described as the first and only immune checkpoint inhibitor in aCSCC that helps restore the adaptive immune function and engage the innate immune system while preserving PD-L2 signaling, which may help maintain immune tolerance in non-tumor tissues.

Study Design and Methodology

The ESMO abstract expands the pivotal analysis to 205 patients across three advanced CSCC cohorts using centrally-reviewed data from the CK-301-101 trial:

  • Group 1: mCSCC patients received 800 mg Q2W (n=78)
  • Group 2: laCSCC patients received 800 mg Q2W (n=64)
  • Group 3: mCSCC patients received 1,200 mg Q3W (n=63)

The primary endpoint was objective response rate (ORR) by central review. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

Key Efficacy Results

Group 1 (mCSCC, 800 mg Q2W, n=78)

  • ORR: 51.3% (CR = 16.7%)
  • Median DOR: 45.9 months with median follow-up of 49.9 months
  • 24-month response estimate for responders: 68.6%
  • Median PFS: 7.9 months

Group 2 (laCSCC, 800 mg Q2W, n=64)

  • ORR: 53.1% (CR = 34.4%)
  • Median DOR: Not reached with median follow-up of 36 months
  • 24-month response estimate for responders: 81.8%
  • Median PFS: 37.3 months

Group 3 (mCSCC, 1,200 mg Q3W, n=63)

  • ORR: 44.4% (CR = 20.6%)
  • Median DOR: Not reached with median follow-up of 29.9 months
  • 24-month response estimate for responders: 73.2%
  • Median PFS: 6.1 months

Overall Survival

  • Median OS was 37.2 months in Group 1
  • Median OS was not reached in Groups 2 and 3

Safety Profile

The tolerability profile was consistent with earlier analyses, with a low level of high-grade immune-related adverse events:

  • 2.9% grade 3 immune-related adverse events
  • No grade 4 events
  • No immune-related adverse events leading to death

Expert Commentary

Dr. Eva Muñoz-Couselo, Medical Oncology, Vall d'Hebron Hospital & Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain, and presenting study co-author, noted: "What is particularly compelling with longer follow-up is not only the durability of response, but also the number of patients who achieved a complete response—a very important outcome for patients living with this disease."

Dr. Nikhil Khushalani, Vice Chair for the Department of Cutaneous Oncology at Moffitt Cancer Center and study co-author, added: "What is particularly notable in these results is the consistency of the benefit-risk profile over time, with response rates maintained with longer follow-up, an increasing proportion of complete responses, and a substantial majority of responders estimated to remain in response at two years."

Company Perspective

Ahmad Naim, MD, Senior Vice President, North American Chief Medical Officer, Sun Pharma, stated: "This dataset is one of the largest ever reported prospective studies of aCSCC patients treated with PD-(L)1 monotherapy and provides important clinical context for the potential of UNLOXCYT to deliver durable clinical benefit for patients with aCSCC."

Future Plans

Sun Pharma continues to investigate furthering access of UNLOXCYT to patients and providers outside the U.S.

Disease Background

Cutaneous squamous cell carcinoma (CSCC) is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths. Important risk factors include chronic ultraviolet radiation exposure and immunosuppressive conditions.

Company's Cutaneous Oncology Focus

Sun Pharma has built on its established leadership in dermatology for over two decades to advance care for people impacted by skin cancer. The company is focused on addressing needs across the disease continuum—from precancerous conditions to advanced skin cancers.

Important Safety Information

The document includes comprehensive safety information covering warnings and precautions for severe and fatal immune-mediated adverse reactions that can occur in any organ system or tissue, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic adverse reactions. Other warnings include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

Presentation Details

  • Presentation Number: 2489P
  • Date and Time: October 24, 2026; 12:00-12:45pm CEST
  • Presenter: Dr. Eva Muñoz-Couselo