Rakuten Medical Launches Phase 3 Trial of Innovative Photoimmunotherapy

Rakuten Medical, Inc., a worldwide biotechnology firm focused on developing and commercializing precision, cell-targeting Alluminox platform-based photoimmunotherapy, declared the launch of its global multi-regional phase 3 clinical trial assessing ASP-1929 photoimmunotherapy alongside anti-PD-1 (pembrolizumab) as a first-line treatment for recurrent head and neck squamous cell carcinoma.

The initial participant in this trial has recently undergone a study treatment at the Avera Cancer Institute located in Sioux Falls, South Dakota, USA. In addition to the US, patient recruitment is planned for locations in Japan and Taiwan, with more countries and areas to follow.

The ASP-1929-381 study is a randomized, open-label phase 3 clinical trial, multi-regional and multi-center in design, aimed at evaluating the safety and efficacy of ASP-1929 photoimmunotherapy alongside pembrolizumab as a first-line approach for locoregional recurrent HNSCC without distant metastasis. Around 400 patients worldwide will be randomly assigned to either a treatment group receiving ASP-1929 photoimmunotherapy along with pembrolizumab, or a control group receiving the existing pembrolizumab-based standard of care (SOC), in which patients may receive pembrolizumab by itself or alongside chemotherapy at the physician's discretion.

The main endpoint is Overall Survival (OS), while important secondary endpoints include Complete Response Rate (CRR) and Overall Response Rate (ORR). This research is based on data from an interim assessment (data cut-off: August 31, 2023) involving 19 patients part of the HNSCC group in an earlier phase 1b/2 study.