- As the first and only PD-L1 immune checkpoint inhibitor approved for aCSCC, UNLOXCYT is an evolution in checkpoint inhibition, offering a balance of durable clinical responses and acceptable tolerability—a key consideration for a patient population that is often living with other comorbidities.
- The pivotal open-label UNLOXCYT trial included patients with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The long-term follow-up analysis demonstrated an improvement in the primary endpoint, objective response rate (ORR), including more complete responses compared with the primary analysis for both groups, with ≥50% of patients experiencing an objective response.
- The median duration of response (DOR) (secondary endpoint) improved with longer follow-up and was not reached in either the mCSCC or laCSCC cohorts at the time of analysis, highlighting the durability of responses observed with UNLOXCYT.
- There were no changes to the safety profile of UNLOXCYT, including immune-mediated adverse reactions (imARs), with this label update.
- The long-term results from the pivotal open-label study of UNLOXCYT in aCSCC were published in the Journal of the American Academy of Dermatology (JAAD), further validating the strength of the data.
MUMBAI, India and PRINCETON, N.J., Nov. 25, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced the U.S. Food and Drug Administration (FDA) approved an updated label for UNLOXCYT™ (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.
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