#USA #Chicago #Rakuten Medical #ASP-1929 #photoimmunotherapy

Rakuten Medical Makes Headlines at ASCO 2025 with New Developments in ASP-1929-381 Trials

Rakuten Medical, Inc., a cutting-edge biotechnology firm recognized for its innovative Alluminox™ platform, has made a noteworthy announcement regarding its ongoing global Phase 3 clinical trial for ASP-1929. This trial examines the combination of ASP-1929 photoimmunotherapy with pembrolizumab (an anti-PD-1) as a pioneering treatment option for recurrent head and neck squamous cell carcinoma (HNSCC). Notably, the company will present a Trial in Progress poster at the prestigious 2025 American Society of Clinical Oncology (ASCO) Annual Meeting set to take place in Chicago from May 30 to June 3, 2025.

The poster presentation is expected to detail the comprehensive progress of the global Phase 3 study (Protocol number ASP-1929-381, Acronym ECLIPSE). This trial is particularly significant, as it aims to validate the synergistic effectiveness of combining ASP-1929 photoimmunotherapy with pembrolizumab as a first-line treatment for individuals battling recurrent HNSCC. Dr. Anastasios Maniakas from The University of Texas MD Anderson Cancer Center, who is involved in the study, emphasized the importance of this research in advancing treatment methodologies for patients facing this challenging form of cancer.

In a remarkable expansion, Rakuten Medical has initiated patient enrollment in Taiwan, broadening its efforts to attract candidates for this essential research. In addition to ongoing recruitment in the United States, with over 10 clinical sites already engaged, a Japanese site is anticipated to commence operations soon. Dr. Kai-Ping Chang from Chang Gung Memorial Hospital in Taiwan expressed optimism regarding the participation in this trial, highlighting that head and neck cancer is a prevalent concern in Taiwan, contributing significantly to cancer-related mortality rates among males. The inclusion of Taiwanese patients in this study represents a vital step toward enhancing therapeutic options that may lead to improved overall survival rates for those diagnosed with recurrent HNSCC.

ASCO 2025 Presentation Details

Rakuten Medical invites all ASCO attendees to visit them at booth #33110 for more information about the ASP-1929-381 study and its broader Alluminox™ platform applications. The Trial in Progress poster will specifically cover:

• - Abstract Title: A phase 3 randomized study of ASP-1929 photoimmunotherapy in combination with pembrolizumab versus standard of care in locoregional recurrent head and neck squamous cell carcinoma (HNSCC)
• - Abstract Number: TPS6122
• - Abstract Link: ASCO Abstract
• - Presentation Date: June 2, 2025
• - Timing: 9:00 a.m. – 12:00 p.m. CDT
• - Location: Exhibit Hall A, Poster Board #523b

About the ASP-1929 Study

The ASP-1929-381 trial is designed as a multi-regional, multi-center, randomized, open-label Phase 3 study. This trial aims to evaluate the efficacy and safety of the ASP-1929 photoimmunotherapy combined with pembrolizumab as a first-line treatment against locoregional recurrent HNSCC without distant metastases. A total of 412 patients globally will be randomized into two arms—one receiving the experimental treatment and another receiving the current standard of care based on pembrolizumab. The primary endpoint for this critical study is Overall Survival (OS), while key secondary metrics will focus on the Complete Response Rate (CRR) and Overall Response Rate (ORR).

Looking Ahead

The company remains committed to addressing the needs of cancer patients globally through the advancement of innovative treatment protocols. The Alluminox™ platform which forms the foundation of Rakuten Medical's therapy has showcased promising results in pre-clinical studies, signaling a potential leap forward in oncology treatment.

This exciting period in oncology promises groundbreaking changes, and Rakuten Medical's efforts at ASCO 2025 will undoubtedly contribute to the ongoing conversation surrounding innovative cancer therapies. With ongoing enrollment efforts in Taiwan and the USA and the forthcoming presentation at ASCO, the future of ASP-1929 photoimmunotherapy looks promising as a novel approach to treating challenging cases of HNSCC.

Conclusion

As the 2025 ASCO meeting approaches, Rakuten Medical’s commitment to innovation and patient care exemplifies the strides being made in biotechnology and cancer treatment. Continued collaboration and dedication to the advancement of medical practices will pave the way for more effective treatments, ultimately enhancing the lives of patients dealing with head and neck cancer.