Nanobiotix amends protocol for phase 3 head and neck cancer study
Nanobiotix has received FDA approval to amend its NANORAY-312 study protocol, a move designed to accelerate the final analysis of its lead oncology candidate.
Biotechnology firm Nanobiotix has announced that the U.S. Food and Drug Administration (FDA) has accepted a protocol amendment for its phase 3 clinical trial, NANORAY-312. The study, which focuses on locally advanced head and neck squamous cell carcinoma, is being managed by global study sponsor Johnson & Johnson.
The amendment eliminates a previously scheduled interim analysis and modifies the final analysis to require a smaller number of clinical events. This change is intended to speed up the registration pathway for the drug candidate, JNJ-1900 (NBTXR3). Nanobiotix anticipates that the results from this revised final analysis will be available in the same window originally projected for the interim report.
JNJ-1900 is an intratumorally injected nanoparticle therapy activated by radiotherapy. Under a global licensing agreement established in 2023, Nanobiotix is eligible for milestone payments tied to the development and regulatory progress of this product. The company maintains that the physical mechanism of the treatment could be applicable to a wide range of solid tumors treated with radiation therapy.