On May 26, 2026 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, (together with its subsidiaries and/or affiliated companies, "Sun Pharma") reported the company will share updated results from the locally advanced cutaneous squamous cell carcinoma (laCSCC) expansion cohort from the pivotal CK-301-101 trial of UNLOXCYT (cosibelimab-ipdl) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31, 2026 in Chicago.
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In the investigator-reviewed data being presented at ASCO (Free ASCO Whitepaper), 64 patients with laCSCC received ≥1 dose of UNLOXCYT. The median age of patients in the cohort was 77 years old and 66% were male. This reflects the population commonly seen in clinical practice. Patients received a median of 29 doses over a median treatment duration of 60 weeks. The objective response rate was 50%, including 17 (27%) complete responses and 15 (23%) partial responses. Over a median follow-up of 31 months, responses were durable and the median duration of response was not yet reached.
"These data support clinically meaningful efficacy within this patient population. We observed a high rate of complete responses in patients with laCSCC, which is associated with long-term clinical outcomes. The durability of these responses, a primary therapeutic objective, was achieved alongside a manageable safety profile," said Rahul Ladwa, MBChB, BSc, FRACP, MPhil, Medical Oncologist at the Princess Alexandra Hospital and Greenslopes Private Hospital; Associate Professor, The University of Queensland, Australia; and presenting study co-author at ASCO (Free ASCO Whitepaper).
The safety profile was comparable to what was observed in an earlier analysis of a smaller cohort.
The most common adverse events (AEs) were anemia and diarrhea, recorded in 17 (27%) patients each.
Immune-related adverse reactions (irAEs) were observed in 22 (34%) patients.
Grade ≥3 irAEs occurred in 1 (2%) patient and were dermatologic in nature (maculo-papular and pruritic rashes) and considered treatment-related.
Treatment-emergent AEs (TEAEs) were reported in 61 (95%) patients and considered treatment-related in 50 (78%) patients; none were fatal.
Grade ≥3 TEAEs were reported in 26 (41%) patients and considered treatment-related in 7 (11%).
"The findings from this large cohort of patients are impressive from both an efficacy and tolerability perspective. Patients with laCSCC are older and have many comorbidities, so we need treatment options that are both efficacious and well tolerated, so patients remain on therapy and experience meaningful benefit," said Emily Ruiz, MD, MPH, Associate Professor of Dermatology, Harvard Medical School, Academic Director of the Micrographic Surgery Center at Brigham and Women’s Hospital; co-founder of Skin Cancer Champions; and study co-author. "Cosibelimab seems to work differently than other checkpoint inhibitors by restoring the adaptive immune response and engaging the innate immune system while preserving the PD-1/PD-L2 pathway. We believe this may explain the results we observe in these patients."
Poster Presentation Details
Title: Efficacy and safety of cosibelimab 800 mg every 2 weeks for locally advanced cutaneous squamous cell carcinoma: Updated follow-up from a pivotal study
Poster Session: Melanoma/Skin Cancers
Abstract Number: 9585
Poster Board Number: 301
Date and Time: May 31, 2026; 9:00am-12:00pm CDT
Presenter: Dr. Rahul Ladwa
"We’re looking forward to presenting these data at ASCO (Free ASCO Whitepaper)’s Annual Meeting later this month, highlighting pivotal results from the second largest ever reported prospective study of laCSCC patients treated with PD-(L)1 monotherapy, reinforcing our commitment to the skin cancer community," said Ahmad Naim, MD, Senior Vice President, North America Chief Medical Officer, Sun Pharma. "With a median duration of response not yet reached after more than two and a half years of follow-up, UNLOXCYT continues to demonstrate the kind of clinically meaningful efficacy with durable clinical responses and well-tolerated treatment option that patients with laCSCC need."
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. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.
UNLOXCYT (cosibelimab-ipdl) was approved at 1,200 mg Q3W because PK/PD modeling showed it provides similar overall exposure and PD-L1 receptor coverage as the trial regimen of 800 mg Q2W. Since checkpoint inhibitors have flat exposure-response curves, they have been utilized with more convenient dosing schedules if equivalent efficacy and safety are maintained. The safety analyses included patients who received both 800 mg Q2W and 1,200 mg Q3W.
About Cutaneous Squamous Cell Carcinoma
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 for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear.
(Press release, Sun Pharma, MAY 26, 2026, https://www.prnewswire.com/news-releases/at-the-asco-2026-annual-meeting-sun-pharma-to-present-pivotal-long-term-follow-up-data-on-unloxcyt-cosibelimab-ipdl-302781880.html [SID1234666065])