Checkpoint Therapeutics Shares Promising Data for Cosibelimab

Checkpoint Therapeutics Unveils Long-Term Efficacy of Cosibelimab

Checkpoint Therapeutics, Inc. (Nasdaq: CKPT), an innovative leader in immunotherapy and targeted oncology, has revealed exciting new data regarding cosibelimab, an anti-PD-L1 antibody, aimed at treating locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC). This pivotal information was presented at the recent European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, emphasizing the ongoing commitment of Checkpoint to advance cancer treatment options.

Significant Findings from the Trial

The long-term results from the clinical trial indicate a notable increase in both objective response rates (ORRs) and complete response rates (CRRs) after an extended follow-up period post-initial analysis. James Oliviero, President and CEO of Checkpoint Therapeutics, expressed optimism regarding cosibelimab’s potential as a leading immunotherapy option for cSCC in the U.S. “These longer-term results demonstrate a deepening of response over time, marking a significant step forward in our clinical journey,” he asserted.

Data Highlights: Efficacy and Safety

The trial provided compelling efficacy data, showcasing increasing ORRs and CRRs in 109 patients. Specifically, patients with advanced cSCC achieved ORRs of 54.8% and 50.0% for locally advanced and metastatic cases, respectively. Notably, complete responses rose to 25.8% and 12.8% in these patient groups. Importantly, the duration of response remains promising, with median durations not yet reached, revealing the potential for sustainable therapeutic benefits.

Safety Profile of Cosibelimab

In terms of safety, cosibelimab demonstrated a tolerable profile across 192 patients treated in the study. This included a low incidence of treatment-emergent adverse events (TEAEs) and immune-related adverse events (irAEs). In fact, only 3.6% of participants experienced an irAE rated as grade 3, with no grade 4 or higher irAEs reported. Such data underline the drug's potential for a favorable safety ranking compared to current therapies.

Future Outlook and Regulatory Pathway

Looking ahead, Checkpoint Therapeutics is preparing for its upcoming Prescription Drug User Fee Act (PDUFA) goal date on December 28, 2024, regarding its Biologics License Application for cosibelimab. After addressing issues identified in a previous complete response letter from the FDA, the company aims to bolster the application with this newly gathered data. The team remains hopeful that if approved, cosibelimab will be a game-changer for oncologists treating cSCC.

Understanding Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma stands as the second most prevalent form of skin cancer in the United States. It presents significant challenges, particularly in advanced stages where treatment options become limited. With an approximate annual incidence of 1.8 million cases, cSCC poses serious health risks, highlighting the urgent need for innovative therapies like cosibelimab.

Importance of New Treatments

Understanding cSCC's aggressive nature and its potential manifestations emphasizes the need for effective immunotherapies. Cosibelimab, a high-affinity fully-human monoclonal antibody, interrupts PD-L1 interactions, potentially reversing immune suppression in tumor environments. Its mechanism of action, coupled with the ability to induce antibody-dependent cellular cytotoxicity (ADCC), positions the drug as a potential cornerstone in the therapy landscape.

About Checkpoint Therapeutics

Founded by Fortress Biotech, Inc. (Nasdaq: FBIO), Checkpoint Therapeutics is dedicated to developing avant-garde therapeutic approaches for solid tumors. Research is focused on pioneering treatments for recurrent or metastatic cancers, including its leading candidates, cosibelimab and the small-molecule olafertinib for EGFR mutation-positive non-small cell lung cancer. Based in Waltham, Massachusetts, Checkpoint is paving the way for next-generation cancer therapies.

Frequently Asked Questions

What is cosibelimab?

Cosibelimab is an anti-PD-L1 monoclonal antibody developed by Checkpoint Therapeutics aimed at treating advanced cutaneous squamous cell carcinoma.

What were the key findings presented at ESMO Congress 2024?

The data showed improved objective response rates and complete response rates, indicating a deepening response over time in patients treated with cosibelimab.

What is the safety profile of cosibelimab?

Cosibelimab exhibited a manageable safety profile with low rates of treatment-emergent adverse events, enhancing its potential as a treatment option.

When is the PDUFA goal date for cosibelimab?

The FDA has set the PDUFA goal date for cosibelimab's Biologics License Application for December 28, 2024.

What is the significance of cSCC in cancer treatment?

Cutaneous squamous cell carcinoma is significant due to its high incidence and potential for severe health complications, making treatments like cosibelimab critical.

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