Announcement • May 26
Sun Pharmaceutical Industries Limited Presents Updated Results from Locally Advanced Cutaneous Squamous Cell Carcinoma Expansion Cohort from Pivotal CK-301-101 Trial of UNLOXCYT (Cosibelimab-Ipdl) at ASCO 2026 Annual Meeting
Sun Pharmaceutical Industries Limited announced 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) Annual Meeting on May 31, 2026 in Chicago. In the investigator-reviewed data being presented at ASCO, 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. 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. 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%). 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. 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. 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. INDICATIONS AND USAGE: 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. It is not known if UNLOXCYT is safe and effective in children. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. IMPORTANT SAFETY INFORMATION: WARNING AND PRECAUTIONS: Immune-mediated Adverse Reactions: Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction, and solid organ transplant rejection. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. While such adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue UNLOXCYT based on the severity of reaction. Infusion-Related Reactions: Infusion-related reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins. Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic Hematopoietic Stem Cell Transplantation (HSCT) before or after being treated with a PD-1/PDL1 blocking antibody. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT. Embryo-Fetal Toxicity/Females and Males of Reproductive Potential: UNLOXCYT can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential prior to initiating UNLOXCYT. Females should use effective contraception during treatment with UNLOXCYT and for 4 months after the last dose. Advise female patients not to breastfeed during treatment with UNLOXCYT and for 4 months after the last dose. ADVERSE REACTIONS: The most common adverse reactions (=10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.