FDA declines to approve Checkpoint's skin cancer therapy cosibelimab
18 Dec 2023
ImmunotherapyClinical ResultDrug ApprovalADCAccelerated Approval
Checkpoint Therapeutics announced Monday that it received an FDA complete response letter regarding its application for the anti-PD-L1 antibody cosibelimab to treat patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. The company, whose shares declined as much as 42% on the news, said the letter cited issues at a third-party contract manufacturer.
The marketing application was supported by a pivotal trial in which cosibelimab achieved its primary endpoint with a confirmed objective response rate (ORR) of 47.4% based on a review of 78 patients enrolled in the metastatic cSCC cohort. Median duration of response, based March 2022 cutoff, had not been reached, although the longest duration at that point was 32-plus months., according to analysts at Ladenburg Thalmann.
Later results found that the drug was associated with a confirmed ORR of 54.8% among 31 patients enrolled in the trial's locally advanced cSCC cohort. When those data were release in June 22, Checkpoint noted that the benefit "substantially [exceeded] a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%."
Updated metastatic cSCC data, from a January 2023 data cut, show the ORR increased to 50%, while it remained at roughly 55% for locally advanced cSCC patients. The study was recently published in the Journal for ImmunoTherapy of Cancer.
Issues at third-party manufacturer
According to Checkpoint, the FDA's letter "only cites findings that arose during a multi-sponsor inspection of [the company's] third-party contract manufacturing organisation as approvability issues to address in a resubmission." However, the the company noted that the FDA's letter did not raise any concerns about the clinical data package, safety or labeling for cosibelimab.
"As the only deficiencies relate to the FDA's inspection of our third-party contract manufacturing organisation, we believe we can address the feedback in a resubmission to enable marketing approval in 2024," said CEO James Oliviero.
Prior to the FDA decision, analysts at Ladenburg Thalmann suggested "the compelling efficacy and safety profile of cosibelimab could enable it to become the first approved PD-1/PD-L1 with competitive pricing."
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