On May 22, 2025 Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox platform-based photoimmunotherapy, reported that it will present a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 30 – June 3, 2025, in Chicago, Illinois (Press release, Rakuten Medical, MAY 22, 2025, View Source [SID1234653328]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster will feature Rakuten Medical’s ongoing global Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab (anti-PD-1) as a first-line therapy for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). The poster will also highlight interim findings from the completed Phase 1b/2 study (ASP-1929-181 / ClinicalTrials.gov Identifier: NCT04305795) which evaluated ASP-1929 photoimmunotherapy in combination with anti-PD-1 in recurrent or metastatic HNSCC.

"We are honored that our Trial in Progress poster has been accepted for presentation at ASCO (Free ASCO Whitepaper) 2025," said Anastasios Maniakas, MD, PhD, Assistant Professor in the Department of Head and Neck Surgery and an investigator of the ASP-1929-381 study at The University of Texas MD Anderson Cancer Center. "This Phase 3 study represents a significant step forward in evaluating the potential synergistic efficacy of ASP-1929 photoimmunotherapy and pembrolizumab as a first-line treatment for patients with recurrent HNSCC. We look forward to sharing our progress with the global oncology community and advancing innovative approaches for the treatment of patients facing this challenging disease."

Rakuten Medical is also pleased to announce that it has recently initiated patient enrollment in Taiwan as part of its global expansion of the Phase 3 ASP-1929-381 study. Currently, over 10 clinical sites across the United States and Taiwan are actively enrolling patients. Additional sites are expected to be activated in both regions, with patient enrollment in Japan anticipated to begin shortly.

"We are pleased to be part of this global Phase 3 study and to contribute to the development of an innovative treatment approach like photoimmunotherapy," said Kai-Ping Chang, MD, PhD, Professor of the Department of Otolaryngology – Head & Neck Surgery and Principal Investigator of the ASP-1929-381 study at Chang Gung Memorial Hospital in Taiwan. "Head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan1. Local recurrence or metastasis is one of the leading causes of death in these patients2, and nearly half of those with recurrent or metastatic disease survive for less than one year3. By participating in this trial, we hope to help advance new therapeutic options that may prolong overall survival of patients with recurrent HNSCC, both in Taiwan and around the world."

ASCO attendees are invited to visit Rakuten Medical at booth #33110 to learn more about the ASP-1929-381 study and the company’s broader Alluminox platform.

Rakuten Medical’s Trial in Progress Poster Overview

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: View Source
Session: Poster Session – Head and Neck Cancer
Date: Monday, June 2, 2025
Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: Anastasios Maniakas, The University of Texas MD Anderson Cancer Center, TX, the U.S.
Location: Exhibit Hall A, Poster Board # 523b
Rakuten Medical Exhibit Booth

Location: Exhibit Hall A, Booth #33110
Exhibit Date: Saturday – Monday, May 31 – June 2, 2025
About ASP-1929-381 Study
The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. 412 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician’s choice.
The primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR).