, /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary AlluminoxTM platform, today announced the updated safety and efficacy findings from an interim evaluation of an open-label Phase /2 study (ASP-1929-181/ClinicalTrials.gov Identifier: ) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 for recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC).
The data will be presented in a poster at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024) on . The updated interim evaluation (data cut-off: ) of 19 enrolled patients in ASP-1929-181 study suggests that the novel treatment approach of ASP-1929 photoimmunotherapy in combination with anti-PD-1 showed promising early results in patients with locoregional and/or metastatic HNSCC. Median overall survival (OS) was not reached at data cut-off, with an estimated survival rate of 52.
4% at 24 months, and an objective response rate (ORR) of 35.3%. Adverse events were generally manageable, and the combination therapy was generally tolerated with an absence of synergistic serious adverse events.
The encouraging early efficacy and safety outcomes warrant additional clinical studies to substantiate and reinforce these interim findings. Rakuten Medical recently completed a Type B End-of-Phase 2 (EOP2) meeting with the U.S.
Food and Drug Administration (FDA) for the combin.
