Nanobiotix reports 70% one-year survival for JNJ-1900 in Phase 1 NSCLC trial
- One-year overall survival reached 70% in Phase 1 NSCLC trial
- No dose-limiting toxicities observed among 24 enrolled patients
- Intratumoral injection deemed feasible with no drug-related Grade 3+ adverse events
- Additional patient enrollment planned following completion of dose-escalation phase
*this image is generated using AI for illustrative purposes only.
Nanobiotix (NASDAQ: NBTX) reported encouraging Phase 1 safety and efficacy data for JNJ-1900 (NBTXR3) in patients with inoperable, locoregionally recurrent non-small cell lung cancer (NSCLC). The study, sponsored by The University of Texas MD Anderson Cancer Center, demonstrated a one-year overall survival rate of 70% with no dose-limiting toxicities observed among the 24 enrolled patients.
The findings were presented by principal investigator Saumil Gandhi, MD, PhD, at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer in Seoul. The trial evaluated radiotherapy-activated JNJ-1900 as a treatment for patients amenable to re-irradiation, a setting where normal tissue tolerance often limits radiation doses to palliative levels.
Clinical Results and Safety Profile
All 24 patients in the pooled dose-escalation and expansion phases completed treatment. Investigators reported no Grade 3 or higher adverse events related to JNJ-1900 or the injection procedure, confirming the feasibility of intratumoral injection. However, Grade 3 radiotherapy-related adverse events occurred in 33% of patients (n=8), and Grade 5 events occurred in 8% (n=2). The recommended Phase 2 dose was established at 33% of gross tumor volume.
| Metric | Result |
|---|---|
| One-year locoregional control | 79% |
| One-year local progression-free survival | 61% |
| Median local progression-free survival | 13.6 months |
| One-year overall survival | 70% |
| Median overall survival | 14.8 months |
| Dose-limiting toxicities | None |
The median follow-up period was 12 months, with data cutoff in August 2026. Investigators concluded that JNJ-1900 may permit clinically meaningful local control using a substantially lower re-irradiation dose than patients received in their prior course of radiotherapy.
What the Numbers Show
The divergence between the absence of drug-related severe toxicity and the presence of radiotherapy-related Grade 3 and 5 adverse events highlights the specific risk profile of re-irradiation. While JNJ-1900 itself showed no Grade 3+ adverse events, 33% of patients experienced Grade 3 radiotherapy-related toxicity. This suggests that while the nanoparticle enhances efficacy at lower doses, the cumulative effect on previously irradiated tissue remains a significant clinical consideration requiring careful management.
Strategic Context and Next Steps
Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix, stated that the team is encouraged by the findings in one of the most difficult settings in lung cancer. He noted that if a physics-based approach can improve local control in tissue that has already failed radiation at a reduced dose, conditions in earlier settings with full-dose radiotherapy could be more favorable.
Enrollment in the dose-escalation and expansion parts of the study is complete per protocol. Following these findings, additional patient enrollment is planned. Nanobiotix has engaged in a collaboration strategy to expand development of JNJ-1900, including a broad clinical research collaboration with UT MD Anderson since 2019.
In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies led by Johnson & Johnson include NANORAY-312, a global randomized Phase 3 study in head and neck squamous cell cancers; LUMIRAY, a Phase 1b study in head and neck squamous cell cancers; and CONVERGE, a Phase 2 study in non-small cell lung cancer.
How might the observed 33% rate of Grade 3 radiotherapy-related adverse events influence the risk-benefit assessment for regulatory approval in re-irradiation settings?
What specific timelines and milestones are expected for the upcoming Phase 2 enrollment following the completion of the dose-escalation phases?
To what extent could the success of JNJ-1900 in NSCLC accelerate the development pipeline for Johnson & Johnson's ongoing Phase 3 NANORAY-312 study in head and neck cancers?
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