Publication of Phase II Randomized Controlled Trial Results of BNCT for Recurrent High-Grade Meningioma in Neuro-Oncology, a journal of the Society for Neuro-Oncology
Stella Pharma Corporation announces that the results of the Phase II randomized controlled trial*1 of Boron Neutron Capture Therapy (BNCT*2) for patients with recurrent high-grade meningioma*3, which was conducted as an investigator-initiated clinical trial*4, have been published in Neuro-Oncology, an international peer-reviewed medical journal.
Neuro-Oncology is the official journal of the American Society for Neuro-Oncology, the Japan Society of Neuro-Oncology, the European Association of Neuro-Oncology, and the World Federation of Neuro-Oncology Societies, and is widely recognized as a leading international journal in the field of neuro-oncology.
The results of this trial were presented in a poster session by Dr. Shinichi Miyatake of Osaka Medical and Pharmaceutical University, the coordinating investigator for this trial, at the American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, Illinois, USA from May 30 to June 3, 2025. Detailed results were published in this paper.
This study is the world’s first randomized controlled trial to evaluate the efficacy and safety of Borofalan (10B) (development code: SPM-011), a boron-containing drug currently under development by our company, in which accelerator-based BNCT is used as the test treatment group and the best available treatment by the treating physician is used as the control group. Furthermore, the study design allows the administration of BNCT as rescue treatment in case of tumor progression after treatment in the control group.
The primary endpoint, progression-free survival (PFS)*5 as assessed by an independent review committee, was 14.4 months (95% Confidence Interval: 7.9–26.4) in the study treatment group and 1.4 months (95% Confidence Interval: 1.0–9.0) in the control group, demonstrating a statistically significant difference (p=0.0157, Log-rank test).
Regarding the secondary endpoint of response rate (complete response (CR) + partial response (PR)), a response was confirmed in 27.3% of patients in the BNCT treatment group, while no response was confirmed in the control group. Additionally, overall survival rates in the BNCT treatment group were 100% at 1 year and 90.9% at 2 years.
Using the results of this study, we are currently preparing to submit a partial change application to the regulatory approval for additional indications during this fiscal year. We will continue our efforts to advance development with the goal of providing BNCT as a treatment option to patients as soon as possible.
For more information on the paper, please visit the Neuro-Oncology website following this link: https://doi.org/10.1093/neuonc/noaf279
*1 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.
*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 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 Investigator-initiated trial
An investigator-initiated trial is a clinical trial conducted by a physician who plans and designs the clinical trial for the purpose of obtaining approval for the manufacture and sale of a drug, submits a clinical trial plan notification, and then conducts the trial. The obtained clinical data is passed on to the pharmaceutical company that provided the investigational drug and used in the drug’s regulatory approval application. This trial was conducted with support from the Japan Agency for Medical Research and Development (AMED), a national research and development agency.
*5 Progression-free survival
Progression-free survival is one indicator to measure the effectiveness of cancer treatment. It shows the period after treatment until progression or recurrence of cancer, or the time until the death of the patient.
About Stella Pharma Corporation
In accordance with our company philosophy “For a precious and irreplaceable life” we strive to “shed a new light on global healthcare” and our management guidelines are based on this principle.
From our beginning we have been working on research and development of BNCT boron drugs in order to realize BNCT for practical use as new treatment option for cancer patients.
Website: https://stella-pharma.co.jp/en/
Contact: Stella Pharma Corporation, General Affairs Department Contact form: https://stella-pharma.co.jp/en/otioawase/
