Checkpoint Therapeutics Gains FDA Approval for UNLOXCYT™ (cosibelimab-ipdl)

On December 13, 2024, Checkpoint Therapeutics, Inc. announced a significant milestone with the U.S. FDA's approval of UNLOXCYT™ (cosibelimab-ipdl). This approval marks the introduction of the first and only FDA-approved anti-PD-L1 treatment specifically for adults suffering from either metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not suitable candidates for curative surgical or radiation approaches.

UNLOXCYT, a novel therapeutic agent, is administered intravenously at a dosage of 1,200 mg over the course of an hour every three weeks. The approval of this drug heralds a new era for Checkpoint Therapeutics, transitioning the company into a commercial-stage entity poised to enter a U.S. market valued at over $1 billion annually. Unlike other therapies, UNLOXCYT distinguishes itself by targeting PD-L1 instead of the PD-1 receptor, thereby modulating the immune system's anti-tumor response. Additionally, it has shown potential in promoting antibody-dependent cell-mediated cytotoxicity (ADCC), setting it apart from existing treatments.

Advanced cSCC is a challenging form of skin cancer, being the second most prevalent in the United States. Patients with persistent or metastatic forms of the disease often face dire prognoses. There remains a considerable demand for innovative treatments that are both effective and have fewer side effects, particularly for patients with concurrent hematological cancers, organ transplant recipients, or those with autoimmune disorders.

Emily Ruiz, M.D., M.P.H., a prominent figure in dermatologic surgery and skin cancer research, highlighted the significance of UNLOXCYT in the landscape of cSCC treatment. She emphasized its role as the first PD-L1–blocking antibody to achieve clinically meaningful and durable responses in advanced cSCC cases. The drug's dual mechanisms and promising safety profile offer oncologists a vital new tool in immunotherapy for tackling this challenging condition.

The FDA's decision to approve UNLOXCYT was primarily grounded in the results from the CK-301-101 study, which was a multicenter, open-label investigation that included adults with advanced solid tumors, such as cSCC. The study's findings demonstrated substantial objective response rates and prolonged response durations, as verified by an independent central review.

James Oliviero, President and CEO of Checkpoint Therapeutics, expressed gratitude towards the many participants involved in the clinical trials and acknowledged the FDA's cooperation throughout the approval process. The company now turns its attention to developing a strategic plan for the commercial launch of UNLOXCYT.

Cutaneous squamous cell carcinoma presents a significant public health challenge, with an estimated 1.8 million cases occurring annually in the U.S. alone. Factors such as chronic exposure to ultraviolet light and immunosuppression contribute to the risk of developing cSCC. While most cases are treatable with surgery, approximately 40,000 cases each year progress to advanced stages, leading to about 15,000 deaths annually. The disease not only poses a mortality risk but also causes functional and aesthetic impairments, particularly when tumors invade critical areas like the head and neck.

UNLOXCYT, a human IgG1 monoclonal antibody, works by inhibiting the interaction between PD-L1 and its receptors on T cells, thus enhancing the body's immune response against tumors. This therapeutic innovation offers hope and a new line of defense against advanced cSCC, potentially altering the treatment landscape for patients and healthcare providers alike.