Sun Pharma Receives US FDA Label Update Approval for UNLOXCYT
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:
SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, “Sun
Pharma”)) announced the U.S. Food and Drug Administration (FDA) approved an updated
label for UNLOXCYTTM (cosibelimab-ipdl) for the treatment of adults with metastatic CSCC or
locally advanced CSCC who are not candidates for curative surgery or curative radiation. The
updated label now incorporates long-term follow-up data from the pivotal CK-301-101 trial, a
multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC),
which showed patients receiving UNLOXCYT experienced durable clinical responses.
At least 50% of patients in the trial achieved the primary endpoint of objective response. In
addition, 14% of mCSCC patients and 32% of laCSCC patients achieved stable disease. At the
time of the follow-up analysis, the median duration of response had not been reached in either
group. Many clinical trial participants achieved a rapid response; median time to response was
1.9 months (range: 1.6-16.9) and 3.6 months (range: 1.7-10.1) in mCSCC and laCSCC,
respectively.
In the CK-301-101 pivotal trial, the most common adverse reactions (≥10%) were fatigue,
musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus,
edema, localized infection, and urinary tract infection. 53 patients (24%) in this study experienced
imARs (any grade), with a low incidence of high-grade events. Two patients (0.9%) experienced
high-grade imARs; both were Grade 3 dermatologic imARs. There were no treatment-related
deaths.
UNLOXCYT restores the adaptive immune response, enabling T cells to recognize cancer cells
by inhibiting the binding of PD-L1 with PD-1 on T cells and B7.1 on antigen-presenting cells.
UNLOXCYT also engages the innate immune system through an active fragment crystallizable
(Fc) A domain that binds to natural killer (NK) cells to induce antibody-dependent cell-mediated
cytotoxicity (ADCC). UNLOXCYT also spares PD-L2, which may help preserve immune tolerance
in non-tumor tissues, such as the lung and liver, potentially limiting off-target effects and imARs.
“The longer-term results confirm that UNLOXCYT represents an advancement in the available
treatment options for people living with aCSCC,” said Richard Ascroft, CEO, Sun Pharma North
America. “As a company committed to addressing the unmet needs of the patient communities
we support, these pivotal data highlight that more patients responded and maintained their
responses to UNLOXCYT for longer than observed in the primary analysis. The updated label
reinforces UNLOXCYT as an evolution in checkpoint inhibition.”
UNLOXCYT was initially approved by the FDA in 2024. This updated label approval further
underscores Sun Pharma’s commitment to advancing data-driven innovation and expanding
differentiated immunotherapy treatment options within its growing cutaneous oncology portfolio.
With this updated label, Sun Pharma intends to commercially launch UNLOXCYT in early 2026.
“While there have been advances in aCSCC treatment, there still remains a significant unmet
need for therapies that provide durable, long-term efficacy with acceptable tolerability. This is
especially important in this aging population who are dealing with significant comorbidities,” 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 primary author on the long-term analysis publication. “For many
aCSCC patients who are over the age of 65 and dealing with comorbidities, UNLOXCYT provides
an important, new treatment option that balances both efficacy and tolerability.”
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