Nanobiotix Reports Full-Cohort Phase 1 Results for JNJ-1900 (NBTXR3) in Recurrent NSCLC Re-Irradiation
核心洞察
All 24 patients with inoperable, locoregionally recurrent NSCLC completed radiotherapy-activated JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities and no related Grade 3 or higher events.
At a median 12-month follow-up, one-year locoregional control reached 79%, one-year local progression-free survival 61% and one-year overall survival 70%.
Investigators concluded the hafnium oxide nanoparticle radioenhancer may permit clinically meaningful local control at a substantially lower re-irradiation dose than patients' prior radiotherapy course.
Nanobiotix has reported complete full-cohort Phase 1 results for radiotherapy-activated JNJ-1900 (NBTXR3) in patients with inoperable, locoregionally recurrent non-small cell lung cancer (搜索) (NSCLC) amenable to re-irradiation, showing clinically meaningful local control achieved at a lower re-irradiation dose than patients' prior course of radiotherapy. The data, from the completed dose-escalation and expansion phases of a study sponsored by The University of Texas MD Anderson Cancer Center, were presented at the IASLC 2026 World Conference on Lung Cancer, held September 12–15, 2026 in Seoul, Republic of Korea (poster P2.260).
Safety and Feasibility in a Difficult-to-Treat Population
All 24 enrolled patients completed treatment with JNJ-1900 plus re-irradiation with no dose-limiting toxicities. Investigators reported no Grade 3 or higher adverse events related to JNJ-1900 or to the injection procedure, and intratumoral injection was deemed feasible. Grade 3 radiotherapy-related adverse events occurred in 33% of patients (n=8), and Grade 5 radiotherapy-related adverse events in 8% (n=2). The recommended Phase 2 dose was established at 33% of gross tumor volume.
The clinical rationale for the study rests on a dual constraint in this setting: patients who are candidates for re-irradiation are frequently limited to palliative radiation doses because of normal-tissue tolerance, and their recurrent tumors typically harbor the most radiation-resistant cells. Effective strategies to safely deliver radiotherapy doses capable of controlling recurrent tumors remain a significant unmet need.
"Recurrence within a previously irradiated field is one of the least forgiving problems in thoracic oncology," said Saumil Gandhi, MD, PhD, of the Department of Thoracic Radiation Oncology, Division of Radiation Oncology at UT MD Anderson, the study's principal investigator. "The normal tissue near the tumor has already received a full course of radiation, so the dose that can [be] delivered safely during a second course is limited. Additionally, the disease that returns is often more radioresistant because it survived radiation the first time. In this study, JNJ-1900 (NBTXR3) was delivered without dose-limiting toxicities, and we observed clinically meaningful local control at a substantially lower re-irradiation dose. These findings warrant evaluation in a randomized trial."
Efficacy Outcomes at One Year
At a median follow-up of 12 months (data cutoff: August 2026), the one-year locoregional control rate was 79%. One-year local progression-free survival (LPFS) was 61%, with a median of 13.6 months, and one-year overall survival (OS) was 70%, with a median of 14.8 months. Investigators concluded that JNJ-1900 may permit clinically meaningful local control using a substantially lower re-irradiation dose than patients' prior course of radiotherapy.
"The Nanobiotix team is encouraged by these full-cohort findings in one of the most difficult settings in lung cancer," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "If a physics-based approach can improve local control in tissue that has already failed radiation, and do so at a reduced dose, then the conditions in earlier settings, where full-dose radiotherapy reaches previously untreated tissue, could be even more favorable. We look forward to further evaluation in additional patients enrolled to this study and across indications."
Enrollment in both the dose-escalation and expansion parts of the study is complete per protocol. Following the encouraging findings, additional patient enrollment in this study is planned.
Mechanism and Broader Development Program
JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles, administered via one-time intratumoral injection and activated by radiotherapy. Its mechanism of action is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma (搜索) study sponsored by Nanobiotix in 2018.
The product candidate is being evaluated across multiple solid tumor indications as a single agent or in combination. In 2019, Nanobiotix entered a broad clinical research collaboration with UT MD Anderson to sponsor several Phase 1 and Phase 2 studies across tumor types and therapeutic combinations. In February 2020, the US Food and Drug Administration (搜索) granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, in patients with locally advanced head and neck squamous cell carcinoma (搜索) (HNSCC) who are not eligible for platinum-based chemotherapy.
In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 with Janssen Pharmaceutica NV, a Johnson & Johnson company. Johnson & Johnson-led studies include NANORAY-312 (NCT04892173), a global, randomized Phase 3 trial in platinum-based chemotherapy-ineligible, locally advanced HNSCC; LUMIRAY (NCT07219212), a global Phase 1b, open-label study in locally advanced HNSCC; and CONVERGE (NCT06667908), a Phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III NSCLC.
Separately, the CONVERGE study has reported an 85.7% overall response rate and a 57.1% complete response rate in seven patients receiving JNJ-1900 with concurrent chemoradiotherapy and consolidation durvalumab — a complete response rate contrasted against a historical benchmark of less than 5% with chemoradiation alone. Sample size limits any conclusion from that dataset, and no comparator-arm data have been disclosed. The FDA accepted a Johnson & Johnson-sponsored protocol amendment in May eliminating the planned interim analysis and reducing the number of events required for the final analysis, which Nanobiotix said could accelerate the registration pathway.