Sun Pharmaceutical’s updated label for Unloxcyt receives US FDA approval

The U.S. Food and Drug Administration (USFDA) has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not eligible for curative surgery or radiation therapy.

This update incorporates long-term follow-up data from the pivotal, multicenter, open-label trial, CK-301-101, which evaluated 109 patients (31 laCSCC; 78 mCSCC).

Improvements in Clinical Outcomes:

• Objective Response Rate (ORR): The long-term follow-up analysis demonstrated an improvement in the primary endpoint of ORR, including more complete responses compared with the initial primary analysis. At least 50% of patients in the trial achieved an objective response.

• Durability of Response (DOR): The median duration of response (a secondary endpoint) improved with longer follow-up and was not reached in either the mCSCC or laCSCC cohorts at the time of analysis. This highlights the sustained nature of the observed responses.

• Response Speed: Many trial participants achieved a rapid response; the median time to response was 1.9 months and 3.6 months in the mCSCC and laCSCC cohorts, respectively.

Safety Profile and Mechanism of Action:

• Safety Profile: There were no changes to the drug’s safety profile, including immune-mediated adverse reactions (imARs). Only two patients (0.9%) experienced high-grade imARs (Grade 3 dermatologic events), and there were no treatment-related deaths.

• Benefit Balance: The drug is described as an evolution in checkpoint inhibition, offering a balance of durable clinical responses and acceptable tolerability—a key consideration for an aging patient population often living with multiple comorbidities.

• Dual Mechanism: The drug operates by restoring the adaptive immune response (enabling T cells to recognize cancer cells by inhibiting PD-L1 binding with PD-1) while also engaging the innate immune system through an active fragment crystallizable (Fc) domain to induce antibody-dependent cell-mediated cytotoxicity (ADCC).

With this long-term data, the company reinforces its commitment to data-driven innovation. As the first and only PD-L1 immune checkpoint inhibitor approved for aCSCC, the drug establishes a critical new treatment option, especially for patients over the age of 65 with comorbidities.

Source: https://www.pharmabiz.com/NewsDetails.aspx?aid=182710&sid=2