On June 6, 2022 Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the presentation of data from its pivotal trial of cosibelimab in metastatic cutaneous squamous cell carcinoma (cSCC) during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Checkpoint Therapeutics, JUN 6, 2022, View Source [SID1234615709]). Positive top-line results were previously announced in January 2022 .
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Poster Presentation Title: Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma: Results from pivotal cohort
This registration-enabling clinical trial enrolled 78 patients with metastatic cSCC at 24 sites in 8 countries, including Australia/New Zealand (58%), Europe (24%), South Africa (10%), and Thailand (8%), and is being conducted under an Investigational New Drug application with the U.S. Food and Drug Administration. The trial is investigating the safety and efficacy of cosibelimab administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC (lymph nodal or distant metastatic disease). Data from this study is expected to support a Biologics License Application for cosibelimab planned for submission in the fourth quarter of 2022.
Data highlights from the poster include:
Efficacy
Confirmed objective response rate (ORR) by independent central review in the modified intent to treat population of 48.7% (95% CI, 37.0-60.4)
13.2% of patients achieved a complete response in target lesions
Median duration of response (DOR) had not yet been reached at time of analysis; 76% of responses were ongoing
The Kaplan-Meier-estimated probability of maintaining a response at six and 24 months was 88.1% and 72.5%, respectively
Safety
Cosibelimab was generally well tolerated with no unexpected safety signals
The most common adverse events associated with cosibelimab were fatigue (11.5%) and rash (10.3%)
Seven patients (9.0%) experienced a grade 3 treatment-related adverse event (TRAE); no grade 4 or 5 TRAEs were reported
A copy of the poster can be found on the Publications page of the Checkpoint Therapeutics website.
Cosibelimab was licensed by Checkpoint in 2015 from the Dana-Farber Cancer Institute.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately one million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced and an estimated 15,000 people will die from their disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.
About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (ADCC) for potential enhanced efficacy in certain tumor types.