PARIS, France and CAMBRIDGE, Mass. — September 14, 2026
Nanobiotix announced complete Phase 1 safety and efficacy findings for JNJ-1900 (NBTXR3) in patients with inoperable, locoregionally recurrent non-small cell lung cancer (NSCLC) who were eligible for re-irradiation. Data from the completed dose-escalation and expansion phases, presented at the IASLC 2026 World Conference on Lung Cancer, showed that all 24 enrolled patients completed treatment with no dose-limiting toxicities and no Grade 3 or higher adverse events related to JNJ-1900 or the intratumoral injection procedure. At a median follow-up of 12 months, the study reported a 79% one-year locoregional control rate, 61% one-year local progression-free survival and 70% one-year overall survival among evaluable patients. The findings are notable because re-irradiation is constrained by the tolerance of previously treated normal tissue, creating a need for approaches that can improve tumor control without requiring radiation doses comparable to an initial treatment course.
JNJ-1900 Shows Local Control at Reduced Re-Irradiation Dose
The Phase 1 results support further investigation of JNJ-1900 as a radiotherapy-activated approach for recurrent thoracic tumors. The recommended Phase 2 dose was established at 33% of gross tumor volume, while Grade 3 radiotherapy-related adverse events occurred in 33% of patients and Grade 5 radiotherapy-related events occurred in 8%. Investigators reported a median local progression-free survival of 13.6 months and median overall survival of 14.8 months at the August 2026 data cutoff. The study investigators concluded that JNJ-1900 may enable clinically meaningful local control using a substantially lower re-irradiation dose than patients received during their previous radiotherapy course. Nanobiotix described the findings as particularly relevant to a setting where recurrent tumors may be more resistant to radiation and surrounding tissues have already reached substantial radiation exposure. The company said additional evaluation is warranted, including potential randomized investigation, while emphasizing that the current findings come from a Phase 1 study.
Nanobiotix Advances Physics-Based Oncology Platform
JNJ-1900 is an investigational oncology product based on functionalized hafnium oxide nanoparticles administered through a one-time intratumoral injection and activated by radiotherapy. The technology is designed to increase the physical effects of radiation within the injected tumor, with the intended result of enhanced tumor-cell death and subsequent activation of an adaptive immune response. Nanobiotix is evaluating JNJ-1900 across multiple solid-tumor settings as a monotherapy or in combination approaches. The company established a broad clinical research collaboration with The University of Texas MD Anderson Cancer Center in 2019 to support Phase 1 and Phase 2 studies across tumor types and therapeutic combinations. The broader program has also included regulatory and development milestones, including FDA Fast Track designation for NBTXR3 activated by radiation therapy, with or without cetuximab, in locally advanced head and neck squamous cell carcinoma patients ineligible for platinum-based chemotherapy. The platform’s development has expanded further through Nanobiotix’s global license agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, announced in 2023.
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Nanobiotix Plans Additional JNJ-1900 Evaluation
With the completed dose-escalation and expansion phases, Nanobiotix is now preparing for additional clinical evaluation of JNJ-1900 in recurrent NSCLC and other solid tumors. Although enrollment in the original portions of the study is complete according to protocol, the company plans to enroll additional patients following the encouraging full-cohort findings. JNJ-1900 is also being evaluated through Johnson & Johnson-led programs, including the global Phase 3 NANORAY-312 study in locally advanced head and neck squamous cell carcinoma, the Phase 1b LUMIRAY study in locally advanced head and neck cancer, and the Phase 2 CONVERGE study in locally advanced and unresectable Stage III NSCLC. For Nanobiotix, the recurrent NSCLC findings add another clinical dataset to a broader strategy aimed at demonstrating whether its physics-based nanotechnology can expand the therapeutic potential of radiotherapy across different cancer settings. Further patient enrollment and upcoming clinical readouts will be important for determining how the technology performs in larger and potentially controlled studies
Source: Nanobiotix, press release
