gorodenkoff
Nanobiotix (NASDAQ:NBTX) said the first patient in the U.S. was randomized in a global phase 3 trial of NBTXR3 to treat elderly patients with locally advanced head and neck squamous cell carcinoma ((LA-HNSCC)) who are ineligible for platinum-based chemotherapy.
NBTXR3 activated by radiotherapy will be evaluated alone or in combination with cetuximab in the phase 3 study, dubbed NANORAY-312, the company added.
Nanobiotix noted that NBTXR3 is a potentially first-in-class radioenhancer with broad application across solid tumors, with prioritized focus in head and neck cancer.
"We believe data on survival and anti-tumoral response in our proof-of-concept Phase 1 Study 102 continue to support the potential of NBTXR3 as a single agent activated by radiotherapy for the treatment of elderly patients with head and neck cancer and we look forward to reporting additional milestones from our head and neck cancer franchise studies in 2023," said Nanobiotix Co-Founder Laurent Levy.
The company added that phase 3 futility analysis is expected in H2 2023, with interim phase 3 data anticipated in H2 2024.
The first patient in NANORAY-312 was randomized in Europe by Nanobiotix in January, followed by randomization of the first patient in Asia by Nanobiotix's strategic collaborator LianBio (NASDAQ:LIAN) in August, the company noted.
Nanobiotix said the addition of the first patient in the U.S. completes its planned study initiation milestones in 2022.