On October 18, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma ("cSCC"), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Checkpoint Therapeutics, OCT 18, 2023, View Source [SID1234636103]). The paper, entitled, "Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma" (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Patients received cosibelimab 800 mg every two weeks as an intravenous infusion until disease progression or unacceptable toxicity. The study’s primary endpoint was objective response rate ("ORR") assessed by independent central review using Response Evaluation Criteria in Solid Tumors, v.1.1. As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results. Median duration of response was not yet reached. The authors observed that cosibelimab treatment was associated with lower rates of severe immune-related adverse events ("irAEs") as compared with those reported for similar studies of PD-1-targeting agents, concluding that cosibelimab may address an area of unmet clinical need for effective and better tolerated treatments for patients with metastatic cSCC who are ineligible for curative surgery or radiation.
"The conclusions of the study are clear," commented Prof. Philip Clingan of Southern Medical Day Care Centre in Wollongong, Australia, Principal Investigator for this study and first author of the paper. "Cosibelimab is the first PD-L1-blocking antibody to demonstrate a robust and clinically meaningful ORR, with durable responses in participants, and a well-tolerated safety profile in patients with metastatic cSCC. While existing PD-1-blocking antibodies are approved to treat advanced cSCC, many patients don’t respond to treatment, experience severe irAEs or are simply not appropriate candidates for PD-1 therapy treatment, such as those that are immunocompromised, immunosuppressed or with preexisting autoimmune disease. There is therefore a significant need for improved therapies. Cosibelimab, if approved, would offer patients an important new treatment option through its dual activation of both innate and adaptive immunity to induce strong and durable anti-tumor responses, complemented by lower rates of severe adverse events as cosibelimab’s binding to PD-L1 leaves the interaction of PD-1 and PD-L2 unaltered."
"Publication of these data expands the growing evidence supporting the efficacy and safety of cosibelimab," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We are encouraged by recently revealed longer-term data from our pivotal studies of cosibelimab, which demonstrate a deepening of response over time. We believe cosibelimab’s dual mechanism of action and potential favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients upon its potential launch early next year. We continue to work with the U.S. Food and Drug Administration ("FDA") toward the January 3, 2024, action date for our Biologics License Application for cosibelimab."
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma 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 each year. 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 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.