34% of patients with locally advanced disease achieved a complete response (CR) while 17%-21% of metastatic patients achieved a CR

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

MUMBAI, India and HOOFDDORP, Netherlands and PRINCETON, N.J., Oct. 23, 2026 /PRNewswire/ — Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, (together with its subsidiaries and/or affiliated companies, “Sun Pharma”) today announced the company will share updated long-term efficacy and safety results from the locally advanced cutaneous squamous cell carcinoma (laCSCC) and metastatic CSCC (mCSCC) expansion cohorts from the pivotal CK-301-101 trial of UNLOXCYT^® (cosibelimab-ipdl) at the European Society for Medical Oncology (ESMO) Congress on October 24, 2026 in Madrid, Spain.

UNLOXCYT was approved by the U.S. Food and Drug Administration (FDA) in 2024 and is indicated for the treatment of adults with mCSCC or 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 is 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 and may contribute to the observed tolerability profile.

The ESMO abstract expands the pivotal analysis to 205 patients across three advanced CSCC cohorts using centrally-reviewed data. In Group 1, mCSCC patients received 800 mg Q2W, Group 2 included laCSCC patients who also received 800 mg Q2W, and the Group 3 mCSCC cohort of patients received 1,200 mg Q3W. 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.

“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. Together with the consistently low rate of high-grade immune-related adverse events (irAEs), these data reinforce the potential of cosibelimab to provide durable disease control with a manageable safety profile for patients with aCSCC,” said Eva Muñoz-Couselo, MD, MSc, PhD, Medical Oncology, Vall d’Hebron Hospital & Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and presenting study co-author at ESMO. “These data reinforce the potential of cosibelimab in aCSCC, demonstrating consistent responses that persisted over time across cohorts together with a favorable safety profile remained stable with longer follow-up.”

Overall response rates were similar to those reported in previous analyses, with additional complete responses (CRs) observed in the long-term analysis. Among responders, the estimated probability of remaining in response at two years ranged from 69% to 82% across the three cohorts. The safety profile remained consistent with previous analyses:

• In Group 1 (n=78), ORR was 51.3% (CR = 16.7%)
  • Median DOR was 45.9 months with a median follow up of 49.9 months; response estimate at 24-months for responders was 68.6%
  • Media PFS was 7.9 months
• In Group 2 (n=64), ORR was 53.1% (CR = 34.4%)
  • Median DOR was not reached, with a median follow up of 36 months; response estimate at 24-months for responders was 81.8%
  • Median PFS was 37.3 months
• In Group 3 (n=63), ORR was 44.4% (CR = 20.6%)
  • Median DOR was not reached, with a median follow up of 29.9 months; response estimate at 24-months for responders was 73.2%
  • Median PFS was 6.1 months
• Median OS was 37.2 months in Group 1 and not reached in Groups 2 and 3
• Similar to previous analyses, there were few high grade irAEs with 2.9% grade 3 irAEs and no grade 4 events or irAEs leading to death

“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. These findings underscore the potential for cosibelimab-ipdl to deliver clinically meaningful and durable benefit for patients with aCSCC,” said Nikhil Khushalani, MD, Vice Chair for the Department of Cutaneous Oncology at Moffitt Cancer Center and study co-author.

Poster Presentation Details

• Title: Efficacy and Safety of Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Update from a Pivotal Open-label Study with a Median Follow-up of ≥2.5 Years
• Presentation Number: 2489P
• Date and Time: October 24, 2026; 12:00-12:45pm CEST
• Presenter: Dr. Eva Muñoz-Couselo

“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,” said Ahmad Naim, MD, Senior Vice President, North American Chief Medical Officer, Sun Pharma. “These findings of improvements in clinical response and consistent safety profile of low irAEs over time support the unmet need for patients with aCSCC. And reflects Sun Pharma’s continued commitment to advancing care and providing innovative treatment options that address the needs of patients with difficult-to-treat skin cancers.”

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

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.

About Sun Pharma in Cutaneous Oncology
For more than two decades, Sun Pharma has built on its established leadership in dermatology to advance care for people impacted by skin cancer. Working in collaboration with the broader skin cancer community, the company is focused on addressing needs across the disease continuum—from precancerous conditions to advanced skin cancers. With a dedicated cutaneous oncology team and a growing focus in specialty medicines, Sun Pharma applies scientific rigor, real-world insight, and partnership to support meaningful progress in care and improve continuity for patients, caregivers, and clinicians.

Please see the INDICATIONS and IMPORTANT SAFETY INFORMATION below.

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.

IMPORTANT SAFETY INFORMATION

WARNING AND PRECAUTIONS

Severe and Fatal Immune-mediated Adverse Reactions: Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, including, but not limited to, immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, and dermatologic adverse reactions.

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. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. 

Withhold or permanently discontinue UNLOXCYT based on the severity of reaction. If UNLOXCYT requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.

Immune-Mediated Pneumonitis
UNLOXCYT can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

Immune-Mediated Colitis
UNLOXCYT can cause immune-mediated colitis, which may present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding. Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

Immune-Mediated Hepatitis
UNLOXCYT can cause immune-mediated hepatitis, defined as requiring the use of systemic corticosteroids and the absence of a clear alternate etiology. 

Immune-Mediated Endocrinopathies
Adrenal Insufficiency
UNLOXCYT can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity

Hypophysitis
UNLOXCYT can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity 

Thyroid Disorders
UNLOXCYT can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity 

Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis
UNLOXCYT can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity

Immune-Mediated Nephritis with Renal Dysfunction
UNLOXCYT can cause immune-mediated nephritis, defined as the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. 

Immune-Mediated Dermatologic Adverse Reactions
UNLOXCYT can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue UNLOXCYT depending on severity

Other Immune-Mediated Adverse Reactions
Cardiac/Vascular: Myocarditis, pericarditis, vasculitis.
Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy. 

Ocular: Uveitis, iritis, ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur.

Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis. 

Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica. 

Endocrine: Hypoparathyroidism.

Hematologic/Immune: Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-like) Overlap Syndrome, reporting as the co-occurrence of either two or all three adverse reactions. 

Infusion-Related Reactions: UNLOXCYT can cause severe or life-threatening infusion-related reactions. 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 system 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. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).

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.

USE IN SPECIFIC POPULATIONS
Lactation: Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 4 months after the last dose of UNLOXCYT.

To report side effects of UNLOXCYT to FDA: visit www.fda.gov/medwatch or call 1-800FDA-1088. Report SUSPECTED ADVERSE REACTIONS or any side effects or ADEs (adverse drug events) to our Drug Safety Department at 1-800-406-7984 or DrugSafety.USoperations@sunpharma.com (preferred) with as much information as available.

Please see Full Prescribing Information for additional Important Safety Information. 

About Sun Pharmaceutical Industries Limited (CIN – L24230GJ1993PLC019050)
Sun Pharma is the world’s leading specialty generics company with a presence in Innovative Medicines, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as Global Emerging Markets. Sun’s high growth Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on LinkedIn & X (formerly Twitter).

Disclaimer
Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof.

Contacts: Sun Pharma

© 2026 Sun Pharmaceutical Industries, Inc. All rights reserved.
PM-US-ULX-0341 10/26

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