Heron's B10 L-BPA Demonstrates Safety and Efficacy in Recurrent Meningioma Clinical Trial

Source: 工商時報
 

Heron's B10 L-BPA Injection Demonstrates Safety and Efficacy in Phase I/II Clinical Trial for Recurrent Meningioma

Heron Neutron Medical Corp. (TWSE: 7799) announced that its proprietary B10 L-BPA Injection, evaluated in a Phase I/II investigator-initiated clinical trial for recurrent meningioma, has demonstrated promising safety and efficacy outcomes. 

Through Day 169 of follow-up, the study achieved a 100% local control rate, an 83.3% progression-free survival (PFS) rate, and a 100% overall survival (OS) rate. 

According to Heron, this Phase I/II clinical trial was designed to evaluate the safety and efficacy of B10 L-BPA as a boron delivery agent in combination with Boron Neutron Capture Therapy (BNCT) for the treatment of recurrent meningioma. A total of 10 participants were enrolled in the study. 

The primary efficacy endpoints were assessed according to the RECIST v1.1 criteria and included tumor response following treatment with B10 L-BPA combined with BNCT, including Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), and local tumor control.  Secondary endpoints included progression-free survival (PFS) and overall survival (OS). 

The results showed that, in both the modified Intent-to-Treat (mITT) and Per-Protocol (PP) analysis populations, most participants maintained stable disease status throughout the 169-day follow-up period, with no new lesions observed. The local control rate reached 100%. 

Regarding secondary efficacy endpoints, only one participant experienced disease progression during the 169-day observation period, and no deaths were reported. Kaplan-Meier analysis demonstrated a progression-free survival (PFS) rate of 83.3% and an overall survival (OS) rate of 100%. Due to the limited number of progression and mortality events during the follow-up period, the median PFS and median OS have not yet been reached. 

Recurrent meningioma remains an area of significant unmet medical need. Based on epidemiological data from Taiwan and international studies, it is estimated that approximately 1,000 to 2,000 new meningioma cases are diagnosed annually in Taiwan, with a portion of these patients developing high-risk or recurrent disease. 

Current treatment strategies for meningioma primarily consist of surgical resection and radiation therapy. However, therapeutic options remain limited for patients who experience multiple recurrences, are no longer eligible for surgery, or develop recurrence after prior radiation treatment. 

BNCT is a targeted radiotherapy approach in which a boron-containing drug selectively accumulates in tumor cells. Subsequent neutron irradiation triggers a nuclear reaction that destroys cancer cells while minimizing damage to surrounding healthy tissue. In this treatment approach, Heron's B10 L-BPA Injection serves as the boron carrier essential for BNCT.