Checkpoint Therapeutics’ cosibelimab has received FDA approval for treating metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC). The PD-L1 inhibitor is available under the brand name Unloxcyt, which was approved for use in CSCC patients with no curable options through surgery or radiation.
According to a study, cosibelimab showed promising results, achieving a 47% response rate among patients with metastatic CSCC and 48% among those with locally advanced disease. The median duration of response varied between the two groups, but Unloxcyt demonstrated strong responses in both cohorts.
While cosibelimab’s results compared favorably to some data from existing therapies like Keytruda and Libtayo, differences may not be significant due to variations in baseline patient characteristics and follow-up times. The estimated 12-month duration of response probability for Unloxcyt increased to 75.4% and 88.2% in the metastatic and locally advanced patients, respectively.
The FDA’s approval marks Checkpoint Therapeutics’ transition to a commercial-stage company, with potential to compete in the U.S. market valued at over $1 billion annually. However, Unloxcyt may face challenges from established therapies and new entrants like Coherus BioSciences’ Loqtorzi, which has already secured FDA approval for recurrent or metastatic nasopharyngeal carcinoma.
Checkpoint plans to commercialize Unloxcyt through potential partnerships or other corporate development transactions, with a planned launch in 2025. The company will not disclose the price of Unloxcyt yet but said it may be comparable to other approved anti-PD-(L)1 therapies.
Source: https://www.fiercepharma.com/pharma/small-checkpoint-braves-mercks-mighty-keytruda-fda-approval-unloxcyt-skin-cancer