On June 16, 2022 Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation (Press release, Checkpoint Therapeutics, JUN 16, 2022, View Source [SID1234616034]). The design of the interim analysis incorporated recent feedback from the U.S. Food and Drug Administration (FDA) and is intended to potentially support the approval of cosibelimab in this indication. As of the March 2022 data cutoff, the objective response rate (ORR) determined by independent central review (ICR) in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%.
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Based on these positive results, Checkpoint intends to continue discussions with the FDA on the potential addition of locally advanced cSCC as a second indication in the planned Biologics License Application (BLA) targeted for submission later this year. Checkpoint previously reported positive top-line data from a cohort of 78 patients with metastatic cSCC in its pivotal trial of cosibelimab.
"These exciting positive interim results in this cohort of patients suggest a potential second indication for cosibelimab in locally advanced cSCC, which, when added to the potential labeling in the metastatic cSCC setting, could double the market opportunity at launch for cosibelimab globally. Locally advanced cSCC occurs when tumors become large or have grown deep into underlying tissues, muscles, or nerves, destroying nearby healthy tissue, but have not yet spread metastatically to the lymph nodes or other distant locations of the body," said James Oliviero, President and Chief Executive Officer of Checkpoint.
"We believe the data generated to date continue to show cosibelimab as a differentiated and potentially best-in-class anti-PD-L1 antibody, leveraging a two-fold mechanism of action to deliver robust efficacy with a potentially more favorable safety profile due to its binding to PD-L1 rather than PD-1, an attribute reported in scientific literature as associated with lower rates of severe or worse adverse events as compared to anti-PD-1 therapy," continued Oliviero. "Based on this compelling clinical profile, our planned market-disruptive pricing, and our patent protection through at least 2038, we believe cosibelimab has the opportunity to gain meaningful market share in the $32 billion and growing anti-PD-(L)1 class, while significantly lowering the barrier of high out-of-pocket costs patients endure worldwide to access existing premium-priced cancer therapies."
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 1 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.