Nanobiotix: FDA Approves Amendment to NANORAY-312 Phase 3 Trial Protocol
Nanobiotix announced on Monday the FDA's acceptance of an amendment to the global Phase 3 NANORAY-312 study protocol on head and neck cancer. This amendment, submitted by Johnson & Johnson as the global sponsor, modifies the analysis framework and could accelerate the development timeline of the candidate JNJ-1900 (NBTXR3).
Modification of Final Analysis and Removal of Interim Analysis
The amendment removes the initially planned interim analysis and modifies the final analysis by reducing the number of events required for its completion. According to Nanobiotix, this change could allow the revised final analysis to be read at the same time as the initially scheduled interim analysis. The exact timing of this new analysis will depend on the occurrence of clinical events related to the study.
Financial Implications and Development Portfolio
Through its licensing agreement with Janssen Pharmaceutica NV (Johnson & Johnson), Nanobiotix is eligible to receive hundreds of millions of dollars in cumulative payments over the coming years, subject to achieving certain developmental and regulatory milestones. JNJ-1900 (NBTXR3) is a hafnium oxide nanoparticle compound administered through a single intra-tumoral injection and activated by radiotherapy. It is currently being evaluated in several solid tumors, either as a monotherapy or in combination with other treatments.
