Nanobiotix: 79% locoregional control at one year for its Nbtxr3 in phase 1
Nanobiotix communicated on September 14, 2026 the complete results of the dose escalation and expansion phases of a phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with inoperable and recurrent non-small cell lung cancer.
The study, sponsored by MD Anderson Cancer Center, focused on a difficult-to-treat population: patients candidates for reirradiation whose tumors had already survived an initial radiotherapy cycle. The data were presented at the IASLC 2026 World Conference on Lung Cancer in Seoul.
24 patients treated without dose-limiting toxicity
The trial included 24 patients, all of whom completed treatment combining JNJ-1900 (NBTXR3) and reirradiation, without dose-limiting toxicity. Investigators reported no grade 3 or higher adverse events related to the product or intratumoral injection procedure.
Grade 3 adverse events related to radiotherapy occurred in 33% of patients (n=8), and grade 5 events in 8% (n=2). The recommended dose for phase 2 was established at 33% of the gross tumor volume.
One-year locoregional control of 79% at reduced reirradiation dose
With a median follow-up of 12 months (data cutoff in August 2026), the one-year locoregional control rate was 79%. One-year local progression-free survival was 61% (median of 13.6 months) and one-year overall survival was 70% (median of 14.8 months) in evaluable subjects.
According to investigators, these results were achieved at a reirradiation dose significantly lower than that of patients' previous radiotherapy treatment. They concluded that JNJ-1900 (NBTXR3) could enable clinically meaningful local control at reduced dose, and that these data would justify evaluation in a randomized trial.
Additional patient enrollment planned in the study
Enrollment in the dose escalation and expansion phases is complete according to protocol. Following these results, enrollment of additional patients is planned in this same study.
JNJ-1900 (NBTXR3), composed of hafnium oxide nanoparticles activated by radiotherapy, has been the subject since 2023 of a worldwide license agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company. The most advanced program, NANORAY-312, is a randomized global phase 3 study in locally advanced head and neck squamous cell cancers.
