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Phase II trial of the combination of SPM-011 and BNCT System (BNCT30) for unresectable locally recurrent HNSCC or unresectable HNNSCC

Phase II trial of SPM-011 + BNCT30 for unresectable locally recurrent HNSCC or unresectable HNNSCC

21

Of the 21 patients, 8 were diagnosed as locally recurrent head and neck squamous cell carcinoma and 13 with non-squamous cell carcinoma (11 were locally advanced head and neck, and 2 were locally recurrent head and neck).

Consent was obtained from 22 patients, but one case was discontinued before registration, and BNCT was performed on 21 patients. All 21 patients performed BNCT shifted to the post-observation period and transitioned to the follow-up period after completion of the post-observation period.

Adverse events were observed in 21 patients (100%), and adverse events in 21 patients (100%) where its causal relationship to the drug/BNCT could not be denied. Adverse events with an incidence of > 30% were alopecia in 19 patients (90.5%), increased amilarase 18 patients (85.7%), nausea in 17 patients (81.0%), dysgeusia 15 in patients (71.4%) each, parotitis and decreased appetite in 14 patients (66.7%) each, stomatitis in 13 patients (61.9%), vomiting in 10 patients (47.6%), malaise, thirst and radiation skin injury in 9 patients (42.9%) each, conjunctivitis and sialoadenitis in 7 patients (33.3%) each. Serious adverse events were observed in 1 patient (4.8%). The serious adverse event observed was brain abscess (4.8%), and its causal relationship to BNCT could not be ruled out. No adverse events led to the discontinuation of the drug /BNCT.

The response rate (95% confidence interval on both sides) was 42.9% (21.8% - 66.0%) on Day 30, 57.1% (34.0% - 78.2%) on Day 60, and 71.4% (47.8% - 88.7%) on Day 90. The response rate by disease type of Day 90 (95% confidence interval on both sides) was 75.0% (34.9% - 96.8%) for squamous cell carcinoma and 69.2% (38.6% - 90.9%) for non-squamous cell carcinoma.

Duration of response The median (minimum - maximum) duration of response was 2.04 (0.0 - 2.4) months. By disease type, squamous cell carcinoma was 2.04 (1.1 - 2.1) months, and non-squamous cell carcinoma was 2.04 (0.0 - 2.4) months. Disease control rate The disease control rate (95% confidence interval on both sides) was 100.0% (86.7% - 100.0%) on Day 30, 95.2% (76.2% - 99.9%) on Day 60, and 95.2% (76.2% - 99.9%) on Day 90. By disease type, squamous cell carcinomas 100.0% (68.8% - 100.0%) and 87.5% (47.3% - 99.7%), respectively 87.5% (47.3% - 99.7%) and 100.0% (79.4% - 100.0%) for non-squamous cell carcinoma. Complete response rate The complete response rate (95% confidence intervals on both sides) was 4.8% (0.1% - 23.8%), 9.5% (1.2% - 30.4%) and 23.8% (8.2% - 47.2%), respectively, on Day 30, Day 60 and Day 90. By disease type, squamous cell carcinomas 12.5% (0.3% - 52.7%), 25.0% (3.2% - 65.1%), 50.0% (15.7% - 84.3), respectively 0.0% (0.0% - 20.6%), 0.0% (0.0% - 20.6%), and 7.7% (0.2% - 36.0%), respectively, for non-squamous cell carcinomas. Overall survival (95% confidence interval) The Overall survival rate (730 days after BNCT) was 85.2% (60.8 - 95.0%), and survival did not reach the median at the end of the study.

In 21 patients with local recurrent head and neck squamous cell carcinoma or head and neck non-squamous cell carcinoma, the response rate of 90 days after BNCT was 71.4% and the complete response rate was 23.8%. The overall survival rate (730 days after BNCT) was 85.2%.

Nov. 11, 2020

https://www.thegreenjournal.com/article/S0167-8140(20)30890-2/fulltext

No

Sumitomo Heavy Industries, ltd.

ThinkPark Tower, 1-1 Osaki 2-chome, Shinagawa-ku, Tokyo 141-6025, Japan

shoji.kataoka@shi-g.com

Sumitomo Heavy Industries, ltd.

ThinkPark Tower, 1-1 Osaki 2-chome, Shinagawa-ku, Tokyo 141-6025, Japan

+81-3-6737-2570

shoji.kataoka@shi-g.com

completed

June. 27, 2016

Interventional

Multi-center, open label, single armed study

treatment purpose

2

(1) Document consent by his/her own free will
(2) 20 years old or older
(3) 60% of Karnofsky Performance Status (KPS) or higher
(4) The primary lesion is histologically head and neck cancer
(5) At least one measureable lesion in the target lesion site based on RECIST (version 1.1)
(6) Prior radiation therapy satisfying one of the following conditions:
(6) Prior radiation therapy satisfying one of the following conditions:
For locally recurrent squamous cell carcinoma:
- Radiation therapy, fractionation around 2Gy/day, total dose within the range of 40 - 75 Gy
For non-squamous cell carcinoma:
- No prior radiation therapy
- Radiation therapy, not more than 75 Gy of total biologically effective dose
(7) 90 days or more have passed since the last irradiation date of prior radiation therapy for the evaluation target lesion site to the scheduled date of BNCT, except for non-squamous cell carcinoma with no history of prior radiation therapy
(8) Over 90 days of survival is expected after BNCT.
(9) Non problematic disorder (Screening test)

(1) Active multiple primary cancers
(2) Distant metastasis
(3) Active infections requiring systemic treatment
(4) Serious Complications

Both

unresectable locally recurrent squamous cell carcinoma of the head and neck(HNSCC) or unresectable non-squamous cell carcinoma of the head and neck(HNNSCC)

investigational material(s)
Generic name etc : BNCT30 (investigational device)
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : BNCT30:neutron irradiation
Generic name etc : SPM-011(investigational drug)
INN of investigational material : Borofalan(10B)
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : SPM-011: intravenous administration

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
Tumor resuponse (response rate):Tumor response was evaluated within 90 days after BNCT using RECIST (version 1.1). Response rate is defined as the ratio of the number of cases with CR or PR of the evaluated lesions to the number of all eligible cases.

safety
efficacy
[Efficacy]Duration of response, disease control rate, complete response rate, comprehensive evaluation, overall survival
[Safety]Adverse event, clinical examination

+81-24-934-5322

June. 16, 2016

+81-3-3547-5293

June. 16, 2016