Immunotherapy Company Announces FDA Acceptance of BLA Resubmission For cSCC Treatment
Immunotherapy Company Announces FDA Acceptance of BLA Resubmission For cSCC Treatment
Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma.
Disclaimer: The information provided in this article is intended for informational purposes only and does not constitute medical or professional advice. For medical-related concerns, please consult a healthcare professional.
Real-time information is available daily at https://stockregion.net
Checkpoint Therapeutics, Inc. (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, has recently announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for cosibelimab. This investigational anti-PD-L1 antibody is being proposed as a treatment for patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or radiation. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 3, 2024, to make its decision on the application.
Cosibelimab and Its Significance
Cosibelimab is an investigational anti-PD-L1 antibody developed by Checkpoint Therapeutics. It targets the PD-L1 protein, which plays a crucial role in preventing the immune system from attacking normal cells in the body. By inhibiting this protein, cosibelimab helps the immune system recognize and attack cancer cells more effectively. This innovative approach aims to provide a new therapeutic option for patients with cSCC, particularly those who have limited choices due to the advanced stage of their disease or underlying health conditions that preclude surgery or radiation therapy.
The BLA submission is underpinned by positive results from Checkpoint's registration-enabling clinical trials. These trials evaluated cosibelimab in patients with both metastatic and locally advanced cSCC.
In January 2022, Checkpoint announced that the metastatic cSCC cohort met its primary endpoint. The trial demonstrated a confirmed objective response rate (ORR) of 47.4% (95% CI: 36.0, 59.1) based on an independent central review of 78 patients using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). These pivotal results were subsequently presented at the June 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the potential effectiveness of cosibelimab in treating advanced cSCC. In June 2022, Checkpoint also announced positive interim results from its locally advanced cSCC cohort. In this cohort, cosibelimab demonstrated a confirmed ORR of 54.8% (95% CI: 36.0, 72.7) based on an independent central review of 31 patients. These results further supported the potential of cosibelimab as a viable treatment option for patients with locally advanced cSCC.
Following these promising outcomes, Checkpoint engaged in discussions with the FDA to ensure the BLA submission included both the metastatic and locally advanced cSCC indications.
The FDA’s Response
Upon reviewing the BLA submission, the FDA issued an acceptance letter indicating that no potential filing review issues have been identified at this time. Additionally, the FDA has stated that no advisory committee meeting is currently planned to discuss the application. James Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics, expressed his gratitude to the patients and physicians who participated in the clinical studies, as well as to the dedicated team at Checkpoint. He emphasized the importance of this milestone in their endeavor to bring cosibelimab to patients in need as quickly as possible.
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 1.8 million cases according to the Skin Cancer Foundation. Chronic ultraviolet exposure and immunosuppressive conditions are identified as significant risk factors for cSCC. In 2021, approximately 11,000 cSCC patients were treated with systemic therapies in the U.S. However, PD-1 inhibitors comprised less than half of these prescriptions, highlighting the high unmet need for more effective and tolerable treatment options.
Many cSCC patients, particularly those with immunosuppressive conditions or autoimmune diseases, require alternative therapeutic options. Cosibelimab's unique mechanism of action and compelling safety profile suggest it could become a crucial treatment for this underserved patient population if approved. Should the FDA approve cosibelimab by its PDUFA goal date of January 3, 2024, it would introduce a new therapeutic option for patients who currently have limited choices.
Checkpoint Therapeutics remains dedicated to advancing cosibelimab through the regulatory process and ensuring that it reaches patients who stand to benefit from this innovative treatment. The acceptance of the BLA for cosibelimab represents a major milestone for Checkpoint Therapeutics and offers hope for patients with advanced cSCC. As the FDA review process continues, the oncology community awaits the potential approval of this promising new therapy.
Disclaimer: This article is intended to provide general information about recent developments in the field of oncology and should not be construed as medical advice. For personalized medical guidance, please consult a healthcare professional.
Real-time information is available daily at https://stockregion.net