For patients with stage III unresectable non–small cell lung cancer (NSCLC), the first participant has been dosed on the phase 2 CONVERGE study, according to a press release from the late-clinical stage biotechnology company, Nanobiotix.
The randomized, controlled clinical trial is evaluating the potential first-in-class radioenhancer JNJ-1900 (NBTXR3) in patients being treated with standard-of-care chemoradiation followed by consolidation Imfinzi (durvalumab).
“We believe the true value of [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, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. “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] NSCLC brings us another step closer to delivering for the large number of patients [NBTXR3] is designed to serve.”
Who is Eligible For CONVERGE Study Enrollment?
According to the clinical trial page featured on clinicaltrials.gov, CONVERGE is evaluating the addition of NBTXR3 to concurrent platinum-based doublet chemotherapy with radiation therapy, followed by consolidation immunotherapy, and if this enhances the objective response rate in patients with locally advanced, unresectable stage III 3 NSCLC.
To be considered eligible for enrollment, patients must be candidates for chemotherapy with radiation therapy; have a pathologically confirmed NSCLC diagnosis within three months prior to enrollment; 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.
Participants are considered ineligible for enrollment if they have a history of primary immunodeficiency; organ transplantation requiring immunosuppression; significant cardiac events within three months prior to enrollment; concurrent or recent malignancies other than NSCLC; and known hypersensitivity to study drugs or components. Also excluded are patients with active bleeding diathesis or patients requiring anticoagulation or antiplatelet therapy that cannot be safely modified for procedures.
More About NBTXR3
The novel, potentially first-in-class oncology product, NBTXR3, is comprised of functionalized hafnium oxide nanoparticles which are administered via one-time intratumoral injection and activated by radiotherapy. The proof-of-concept for NBTXR3 was demonstrated in soft tissue sarcomas, leading to the agent receiving a European CE mark in 2019.
The mechanism of action of the agent is designed to induce substantial tumor cell death within the injected tumor when activated by radiotherapy, thereby triggering an adaptive immune response and establishing long-term anti-cancer memory. Due to the agent's physical mechanism of action, the Company anticipates that NBTXR3 could apply to any solid tumor treatable with radiotherapy and adaptable to any therapeutic combination, especially with immune checkpoint inhibitors.
The radiotherapy-activated NBTXR3 is under evaluation for multiple solid tumor indications both as a standalone treatment and in combination with anti-PD-1 immune checkpoint inhibitors. These initiatives include the global, randomized phase 3 NANORAY-312 trial, which is focused on locally advanced head and neck squamous cell carcinomas. Notably, the United States Food and Drug Administration (FDA) granted Fast fast tTrack designation to NBTXR3 activated by radiotherapy, with or without cetuximab, for patients with locally advanced HNSCC who are ineligible for platinum-based chemotherapy in February 2020.
Furthermore, in 2019, the Company entered a comprehensive clinical research partnership with The University of Texas MD Anderson Cancer Center to sponsor multiple Phase 1 and Phase 2 trials evaluating NBTXR3 across various tumor types and therapeutic combinations. Subsequently, in 2023, Nanobiotix announced a license agreement with Janssen Pharmaceutica, a Johnson & Johnson company, for the global co-development and commercialization of NBTXR3.
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