Statistically Significant Difference in Results for Primary Endpoint of Clinical Trial for Recurrent High-Grade Meningioma – Presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO)
Stella Pharma is pleased to announce the results of the Phase II investigator-initiated*1 randomized controlled trial*2 of BNCT*3 (Boron Neutron Capture Therapy) on recurrent high-grade meningioma*4.
This was the world’s first randomized controlled trial evaluating the effectiveness and safety of our borofalan (10B) (development code: SPM-011). Borofalan was used in the test treatment group receiving accelerator-based BNCT, and the control group received the best treatment selected by the attending physician.
The study design allows BNCT as a rescue treatment in the event of tumor progression after treatment in the control group.
The primary endpoint of progression-free survival (PFS)*5, as determined by a third-party organization, was achieved 14.4 months (95% CI: 7.93-26.8) in the test group, while the control group reached 1.4 months (95% CI: 0.93-9.13), which is a statistically significant difference (p=0.0157, Log-rank test).
The response rate (the combined percentage of CR and PR) as secondary endpoint was 27.3% in the test group, and no observed response in the control group. In addition, the one-year survival rate in the test treatment group was 100%, and the two-year survival rate in that group was 90.9%.
The results of these studies will be presented in detail at the American Society of Clinical Oncology (ASCO) annual meeting from 30th May to 3rd June 2025 in Chicago, Illinois, USA, by Dr. Shin-Ichi Miyatake of the Osaka Medical and Pharmaceutical University, who served as the coordinating investigator. The poster session will be held on the 31st of May 2025, from 9:00 a.m. to 12:00 p.m., on-site and online.
Details:
Poster Session No.: 129
Abstract No.: 2083
Date: 31st of May 2025, 9:00 a.m. to 12:00 p.m. (Central Daylight Time)
Abstract Title: Accelerator-based boron neutron capture therapy, a randomized controlled trial for refractory recurrent high-grade meningiomas.
We shared these results with the relevant Japanese Authority and continue our effort to obtain the approval. Providing BNCT as a new treatment option to patients is the goal of our development endeavor.
*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 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.
*3 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.
*4 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.
*5 Progression-free survival
Progression-free survival is one indicator to measure the effectiveness of a 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/
