Nanobiotix Reports 41.7% ORR and 17.8-Month Median OS in Anti-PD-1-Resistant Melanoma at ESMO
NBTX has more than doubled off its 52-week low of $14.78.
Summary
At ESMO 2026, Nanobiotix presented final Phase 1 melanoma data: 41.7% ORR, 75% disease control and 17.8-month median OS in 24 anti-PD-1-resistant patients, with responses also in non-injected lesions. Investigators say the results warrant randomized testing.
Key Events · Product Development and Regulatory · NBTX
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Final Melanoma Data at ESMO 2026
In 24 anti-PD-1-resistant primary cutaneous melanoma patients, JNJ-1900 (NBTXR3) plus SBRT and nivolumab or pembrolizumab produced a 41.7% (10/24) ORR per RECIST 1.1, including 4 complete responses, and a 75% (18/24) disease control rate.
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Survival Beats Historical Benchmarks
Median overall survival was 17.8 months and median PFS 6.9 months, versus published medians of roughly one year OS and about three months PFS in this post-progression setting.
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Responses in Non-Injected Lesions
ORR was 45.8% (11/24 evaluable) in injected lesions and 30.0% (3/10 evaluable) in non-injected lesions, supporting an immune-mediated abscopal effect; exploratory analysis in 8 patients showed IL-1β as the most increased plasma cytokine.
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Safety Acceptable, No New Signals
A single intratumoral injection followed by a short course of stereotactic radiotherapy was feasible across a wide range of lesion sizes and locations, with no new safety signals observed.
Analysis · NBTX · Life Sciences
Against published historical medians of roughly one year in this setting, final Phase 1 data for JNJ-1900 (NBTXR3) plus checkpoint inhibitors in 24 heavily pre-treated, anti-PD-1-resistant cutaneous melanoma patients showed a 41.7% overall response rate, 75% disease control and a 17.8-month median overall survival. Responses appeared in non-injected lesions too — the abscopal effect the platform thesis depends on — and an exploratory IL-1β rise offers a mechanistic read. This is single-arm, early-stage evidence in a small cohort, so it supports a randomized trial rather than proving one; commercial value still hinges on the Johnson & Johnson-partnered head and neck Phase 3 (NANORAY-312), not this melanoma cohort.
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At the time of this filing, NBTX was trading at $30.26 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.5B. The 52-week trading range was $14.78 to $57.14. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.