Key Quantitative Figures

  • 64 patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) received ≥1 dose of UNLOXCYT
  • Median age of patients: 77 years
  • 66% of patients were male
  • Median treatment duration: 60 weeks
  • Median number of doses: 29
  • Objective response rate: 50% (32 patients)
  • Complete responses: 27% (17 patients)
  • Partial responses: 23% (15 patients)
  • Median follow-up: 31 months
  • Most common adverse events: anemia and diarrhea (27% each, 17 patients)
  • Immune-related adverse reactions: 34% (22 patients)
  • Grade ≥3 immune-related adverse events: 2% (1 patient)
  • Treatment-emergent AEs: 95% (61 patients)
  • Treatment-related AEs: 78% (50 patients)
  • Grade ≥3 treatment-emergent AEs: 41% (26 patients)
  • Grade ≥3 treatment-related AEs: 11% (7 patients)
  • Infusion-related reactions: 11% (24/223 patients across trials)
  • Grade 2 infusion-related reactions: 5.8% (13/223 patients)

Dates of Action

  • ASCO Annual Meeting presentation date: May 31, 2026
  • Presentation time: 9:00am-12:00pm CDT

Parties Involved

  • Sun Pharmaceutical Industries Limited (issuer)
  • American Society of Clinical Oncology (ASCO)
  • Princess Alexandra Hospital
  • Greenslopes Private Hospital
  • The University of Queensland, Australia
  • Harvard Medical School
  • Brigham and Women's Hospital
  • Skin Cancer Champions
  • Checkpoint Therapeutics, Inc. (trademark owner for UNLOXCYT)

Product Information

UNLOXCYT™ (cosibelimab-ipdl) 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.

Recommended dosage: 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.

The drug was approved at 1,200 mg Q3W based on PK/PD modeling showing similar overall exposure and PD-L1 receptor coverage as the trial regimen of 800 mg Q2W.

Safety Information

Warnings and Precautions:

  • Immune-mediated adverse reactions that can be severe or fatal
  • Infusion-related reactions (11% of patients, Grade 2 in 5.8%)
  • Complications of allogeneic Hematopoietic Stem Cell Transplantation
  • Embryo-Fetal Toxicity

Most common adverse reactions (≥10%):

Fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

Presentation Details

  • Poster Session: Melanoma/Skin Cancers
  • Abstract Number: 9585
  • Poster Board Number: 301
  • Presenter: Dr. Rahul Ladwa

Company Background

Sun Pharma is described as the world's leading specialty generics company with presence in Innovative Medicines, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and a leading generic company in the U.S. and Global Emerging Markets. The company's Innovative Medicines portfolio accounts for about 20% of company sales.

Disclaimer

Contains forward-looking statements within the meaning of applicable securities laws and regulations. The company undertakes no obligation to update or revise forward-looking statements.