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Press Release
Sun Pharmaceutical Industries Ltd · 524715
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Sun Pharmaceutical Industries Ltd will present long-term follow-up data on UNLOXCYT (cosibelimab-ipdl) from a prospective study in advanced cutaneous squamous cell carcinoma (aCSCC) at the ESMO Congress.
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Sun Pharmaceutical Industries Ltd - 524715 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
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Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai – 400 063, Maharashtra, INDIA.
Tel.: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Website: www.sunpharma.com
Email: secretarial@sunpharma.com
CIN: L24230GJ1993PLC019050
23 October 2026
National Stock Exchange of India Limited BSE Limited
Scrip Symbol: SUNPHARMA Scrip Code: 524715
Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations,
2015 – Press Release
Enclosed herewith is a copy of the press release titled “At ESMO 2026, Sun Pharma to Present Long-Term
Follow-up Data on UNLOXCYT® (cosibelimab-ipdl) from One of the Largest Prospective Studies in Advanced
Cutaneous Squamous Cell Carcinoma (aCSCC)” which shall be released after this intimation.
For Sun Pharmaceutical Industries Limited
(Anoop Deshpande)
Company Secretary and Compliance Officer
ICSI Membership No.: A23983
Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA.
Reaching People. Touching Lives.
Sun Pharmaceutical Industries Limited
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai – 400 063, Maharashtra, INDIA.
Tel.: (91-22) 4324 4324
Fax: (91-22) 4324 4343
Website: www.sunpharma.com
Email: secretarial@sunpharma.com
CIN: L24230GJ1993PLC019050
FOR IMMEDIATE RELEASE
At ESMO 2026, Sun Pharma to Present Long-Term Follow-up Data on UNLOXCYT®
(cosibelimab-ipdl) from One of the Largest Prospective Studies in Advanced Cutaneous
Squamous Cell Carcinoma (aCSCC)
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, HOOFDDORP, NETHERLANDS, and PRINCETON, NJ (October 23, 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”) 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 advanc
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