Nanobiotix Reports Full Phase 1 Cohort: 79% Locoregional Control, 70% One-Year Survival in Recurrent NSCLC
NBTX has more than doubled off its 52-week low of $9.32.
Summary
Nanobiotix reported full Phase 1 cohort results for JNJ-1900 in recurrent NSCLC: 79% one-year locoregional control, 70% one-year overall survival, and no dose-limiting toxicities across all 24 patients.
Key Events · Product Development and Regulatory · NBTX
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Full Phase 1 Cohort Results Reported
All 24 patients completed treatment with JNJ-1900 plus re-irradiation with no dose-limiting toxicities and no Grade 3+ adverse events related to JNJ-1900 or the injection procedure.
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Efficacy at Lower Re-Irradiation Dose
At median 12-month follow-up, one-year locoregional control was 79%, local progression-free survival was 61% (median 13.6 months), and overall survival was 70% (median 14.8 months) — achieved at a substantially lower re-irradiation dose than patients' prior radiotherapy.
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Recommended Phase 2 Dose Established
The recommended Phase 2 dose was set at 33% of gross tumor volume, with additional patient enrollment planned following the encouraging findings.
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Randomized Trial Warranted
Study investigators concluded the findings warrant evaluation in a randomized trial, positioning JNJ-1900 for potential advancement in recurrent NSCLC.
Analysis · NBTX · Life Sciences
Complete Phase 1 results for radiotherapy-activated JNJ-1900 (NBTXR3) in inoperable, locoregionally recurrent non-small cell lung cancer — one of the hardest settings in thoracic oncology — were disclosed by Nanobiotix. All 24 patients completed treatment with no dose-limiting toxicities and no Grade 3+ adverse events tied to the drug or injection procedure. At a median 12-month follow-up, one-year locoregional control was 79%, local progression-free survival was 61% (median 13.6 months), and overall survival was 70% (median 14.8 months) — achieved at a substantially lower re-irradiation dose than patients' prior radiotherapy. The recommended Phase 2 dose was set at 33% of gross tumor volume, and additional enrollment is planned. These data support moving toward a randomized trial and strengthen the case for the broader JNJ-1900 franchise, which is already in Phase 3 (NANORAY-312) and Phase 2 (CONVERGE) studies under the Janssen collaboration.
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At the time of this filing, NBTX was trading at $38.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.8B. The 52-week trading range was $9.32 to $57.14. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.