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STELLA PHARMA NEWS
Press Release BNCT
March 4th, 2024

Interim Analysis Results of Post-Marketing Surveillance of Our Drug Product published ― Safety of Boron Neutron Capture Therapy with Borofalan(10B) and Its Efficacy on Recurrent Head and Neck Cancer

The results regarding safety and effectiveness of our product Borofalan(10B), used in Boron Neutron Capture Therapy (BNCT) and approved in 2020, have been published in the online journal “Cancers”. The title is “Safety of Boron Neutron Capture Therapy with Borofalan(10B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance”.

With several executive members and employees of our company as co-authors the paper was published in a special edition about advances in radiotherapy for head and neck cancer.

Due to its cell-selective capacity, BNCT offers a safe and effective treatment for patients who already had undergone radiotherapy. The results of the Phase II clinical trial for unresectable locally advanced or locally recurrent head and neck cancer were indeed promising.

This paper contains the interim results of the ongoing all-case surveillance with the clinical results of 162 patients who received Borofalan(10B) since May 2020. This is the largest number of reported cases in BNCT targeting patients with head and neck cancer.

Among 155 cases of head and neck cancer included in the surveillance, the highest response rate of 137 patients with head and neck squamous cell carcinoma was 72.3% and 63 (46.0%) out of those 137 patients showed complete response (CR). For head and neck non-squamous cell carcinoma the highest response rate out of 17 was 64.7% and 8 (47.1%) out of these 17 patients was CR.

The survival rate for head and neck squamous cell carcinoma for 1 year was 78.8% and for 2 years 60.7%, whereas the 1-year-survival rate for head and neck non-squamous cell carcinoma was 100%. Regarding safety, the treatment-related adverse events were hyperamylasemia (84.0%), stomatitis (51.2%), sialoadenitis (50.6%), and alopecia (49.4%). Common late toxicities included dysphagia (4.5%), thirst (2.6%) and skin disorders (1.9%).

“Cancers” online article: https://www.mdpi.com/2072-6694/16/5/869