Presentation on the Clinical Trial for Recurrent High-Grade Meningioma at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO)
At the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held in Chicago, USA, from May 30 to June 3, we are pleased to announce that a poster presentation has been accepted on the results of the Phase II investigator-initiated clinical trial*1 using BNCT (Boron Neutron Capture Therapy)*2 with borofalan (10B) (development code: SPM-011), which is being developed by our company as a boron drug for recurrent high-grade meningioma*3.
The trial was conducted with the support of the Japan Agency for Medical Research and Development (AMED) and is the world’s first randomized controlled trial*4 for BNCT using an accelerator.
The poster session will be presented by Dr. Shin-Ichi Miyatake of the Osaka Medical and Pharmaceutical University, who served as the coordinating investigator for the trial.
The title of the accepted abstract is as follows, and the abstract and presentation date are scheduled to be released in late May.
Title: “Accelerator-based boron neutron capture therapy, a randomized controlled trial for refractory recurrent high-grade meningiomas.”
ASCO is the world’s leading conference on cancer treatment, held once a year. In 2024 there were approximately 45,000 participants. As the latest findings on cancer treatment being researched around the world are presented at this influential conference, it is famous for being a very competitive conference with researchers applying from all fields of cancer treatment from around the world and only a 10% acceptance rate.
*1 Investigator-initiated clinical trial
In an investigator-initiated clinical trial, the physician personally develops and conducts the clinical trial plan and design including the clinical trial protocol notice required for the manufacturing and sales approval.
The achieved data will then be taken over by the pharmaceutical manufacturer that provided the clinical trial material, and this manufacturer will include these data in the application for regulatory approval of the drug.
*2 BNCT (Boron Neutron Capture Therapy)
Boron Neutron Capture Therapy is one sort of radiation therapy where a reaction between a boron containing drug and thermal neutrons occurs. As new cancer treatment, the damage caused to the body is small and the effectiveness is expected to be high.
*3 Recurrent high-grade meningioma
Meningiomas are categorized into one type of brain tumors that develops in one of the inner layers of the meninges, which are thin layers of tissue that protect the brain and spinal cord. The most common kind of meningioma is benign (WHO grade 1), but if highly malignant (WHO grade 2 or 3), it can deeply invade the brain, cerebrovascular vessels, the skull and recur repeatedly. If recurrent, surgery or radiotherapy (external x-ray radiation) are applicable, but the results are limited and there is no effective treatment developed yet.
*4 Randomized controlled trial
In a randomized controlled trial, the participants are divided at random into at least two groups. One group is treated with the conventional treatment and the other group is treated with the new therapy, and the effects of the treatments are verified by observing and comparing the health conditions of the subjects after the treatment.
