Nanobiotix SA (NASDAQ:NBTX) on Tuesday announced updated data from cohorts 1 and 2 of Study 1100 Phase 1 dose escalation and expansion trial evaluating JNJ-1900 (NBTXR3) activated by radiation therapy (RT) followed by anti-PD-1 immune checkpoint inhibitors (ICI) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma that is naïve (cohort 1) or resistant (cohort 2) to prior anti-PD-1 therapy.
Study results were presented at the 2025 Annual Meeting of the American Society of Radiation Oncology.
The efficacy of ICI monotherapy remains limited in R/M-HNSCC, with objective response rates between approximately 13% and 18%, and median Overall Survival (mOS) between approximately 8 months and 12 months.
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As approximately 66% of patients with R/M-HNSCC experience disease recurrence locally or loco-regionally, the addition of RT to the treatment regimen is often recommended to improve local control and as a potential option for stimulating immune responses.
However, to date, the addition of RT has not significantly improved ICI efficacy in R/M-HNSCC.
Additional efficacy data:
63% (26/41) disease control rate (DCR) and 37% (15/41) objective response rate (ORR) in evaluable anti-PD-1 naïve patients per RECIST 1.1
74% (37/50) DCR and 32% (16/50) ORR in evaluable anti-PD-1 resistant patients.
15.5 months mOS in evaluable anti-PD-1 naïve patients.
11.4 months mOS in evaluable anti-PD-1 resistant patients.
JNJ-1900 (NBTXR3), activated by RT followed by anti-PD-1, was consistently well-tolerated and remained feasible in this heavily pre-treated patient population (n=103).
In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson (NYSE:JNJ) company.
Price Action: NBTX stock was trading higher by 7.49% to $19.37 at last check Tuesday.
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