#United States #Sioux Falls #Rakuten Medical #ASP-1929 #Pembrolizumab

Rakuten Medical Initiates Global Phase 3 Trial for Recurrent Head and Neck Cancer

Rakuten Medical, a prominent global biotechnology firm, has recently announced the initiation of a pivotal Phase 3 clinical trial designed to evaluate the effectiveness of ASP-1929 photoimmunotherapy combined with pembrolizumab for treating recurrent head and neck squamous cell carcinoma (HNSCC). This groundbreaking development is expected to set a new benchmark in oncology treatment by delivering personalized therapies that effectively target cancer cells while minimizing side effects.

The Trial and Its Significance

The clinical trial, referred to as the ASP-1929-381 study, is a multi-regional, open-label, randomized trial. It is structured to assess the safety and efficacy of the treatment in approximately 400 patients globally. Patients will be randomized into two groups: one receiving ASP-1929 combined with pembrolizumab and the other receiving the standard of care based on pembrolizumab alone or in combination with chemotherapy, as determined by physicians.

This study seeks to improve overall survival rates as its primary endpoint, while also measuring secondary outcomes including the complete response rate and overall response rate for the combined therapy.

Dr. Kristen Coffroth of Avera Medical Group, who is involved as an investigator in the study, shares insights on the potential benefits of combining photoimmunotherapy with systemic treatments like pembrolizumab. She stated, "Photoimmunotherapy offers a unique method of targeting and disrupting cancer cells. We hope this trial will showcase the synergistic effects of combining these two approaches to improve patient outcomes."

Background of ASP-1929

ASP-1929 is Rakuten Medical's flagship treatment developed using their Alluminox™ platform, which has shown promise in preclinical studies for its ability to rapidly and selectively induce cancer cell killing. The platform integrates pharmaceuticals and medical devices, employing light-activated therapy where targeted illumination of cancerous cells can activate treatment to improve effectiveness drastically.

This specific therapy targets the epidermal growth factor receptor (EGFR), prevalent in many cancers, including those of the head and neck. Initial studies have shown a 52.4% survival rate after two years among patients in a prior Phase 1b/2 study, paving the way for optimism regarding the new Phase 3 trial.

The Challenge of Head and Neck Cancer

Head and neck cancer is a significant global health challenge, ranking as the seventh most common cancer type. With over 90% of cases identified as squamous cell carcinoma, a substantial number of patients are diagnosed with locally or regionally advanced diseases, negatively impacting their prognosis. Around 15%-40% of these individuals face recurrence, leading to a stark decline in their five-year overall survival rates.

Future Perspectives

The commencement of this clinical trial is vital for expanding the therapeutic options available for patients combating recurrent head and neck cancer. The collaboration between innovative approaches like photoimmunotherapy and established systemic therapies may catalyze new treatment avenues, potentially transforming outcomes for patients in dire need of effective solutions.

Rakuten Medical's vision is to conquer cancer by swiftly developing these novel therapies, making them accessible globally. With offices in key regions like the United States, Japan, and Taiwan, the company is strategically positioned to facilitate international patient participation in this significant trial.

In concluding remarks, Mickey Mikitani, CEO of Rakuten Medical, expressed immense pride in embarking on this Phase 3 journey, emphasizing the potential this trial holds for improving the prognosis of patients with head and neck cancer. As the trial unfolds, the medical community watches closely for promising developments that could reshape the landscape of cancer treatment.

For more details about this ongoing research and its implications in oncology, stay tuned to updates from Rakuten Medical.