Nanobiotix SA has announced the dosing of the first patient in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating JNJ-1900 (NBTXR3) for patients with Stage 3 unresectable non-small cell lung cancer (NSCLC). The trial, sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson company, is designed to assess the efficacy and safety of JNJ-1900 in combination with standard-of-care chemoradiation followed by consolidation durvalumab. This study marks a significant step in Nanobiotix's efforts to expand the application of its novel radioenhancer across various solid tumors.
JNJ-1900: A Novel Radioenhancer
JNJ-1900 (NBTXR3) is a potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles. Administered via a one-time intratumoral injection, NBTXR3 is activated by radiotherapy to induce significant tumor cell death within the injected tumor. This mechanism of action is designed to trigger an adaptive immune response and long-term anti-cancer memory. The physical MoA suggests that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and in combination with immune checkpoint inhibitors.
CONVERGE Study Details
The CONVERGE study (NCT06667908) is a Phase 2 randomized controlled trial evaluating the addition of NBTXR3 to concurrent platinum-based doublet chemotherapy with radiation therapy, followed by consolidation immunotherapy. The primary endpoint is to determine if NBTXR3 enhances the objective response rate in patients with locally advanced, unresectable Stage 3 NSCLC. Key eligibility criteria include patients who are candidates for chemotherapy with radiation therapy, have a pathologically confirmed NSCLC diagnosis, present with unresectable Stage 3IIIA or 3IIIB NSCLC, have at least one target lesion suitable for intratumoral or /intranodal injection and external beam radiation therapy, and have an ECOG performance status of 0 or 1.
Broader Development Program
Beyond NSCLC, radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors. This includes the NANORAY-312 study, a global, randomized Phase 3 trial in locally advanced head and neck squamous cell cancers (HNSCC). In February 2020, the FDA granted Fast Track designation for NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.
Executive Perspective
"We believe the true value of JNJ-1900 (NBTXR3) is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment," said Laurent Levy, Nanobiotix Chief Executive Officer and Chairman of the Executive Board. "With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in non-small cell lung cancer brings us another step closer to delivering for the large number of patients JNJ-1900 (NBTXR3) is designed to serve."
