On June 17, 2020 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) (Paris:NANO), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that the FDA has provided necessary feedback regarding the design of NANORAY-312, the Company’s pivotal phase III global registration trial in head and neck cancer (Press release, Nanobiotix, JUN 17, 2020, View Source [SID1234561195]). The FDA also agreed to the NBTXR3 chemistry, manufacturing, and controls (CMC) Development Plan to support the phase III trial and a future New Drug Application (NDA) for the product.
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NANORAY-312: A Phase III Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma.
NANORAY-312 will be a phase III investigator’s choice, dual-arm, randomized (1:1) global registration trial including elderly head and neck cancer patients who are ineligible for platinum-based chemotherapy.
Patients in the control arm will receive radiation therapy with or without cetuximab (investigator’s choice), and patients in the treatment arm will receive NBTXR3 activated by radiation therapy with or without cetuximab (investigator’s choice).
The trial is expected to recruit approximately 500 patients. A futility analysis is expected 18 months after the first patient in the trial is randomized, and the interim analysis for progression-free survival (PFS) superiority is expected at 24-30 months. The final analysis will report on PFS and overall survival. Quality of Life will also be measured as a key secondary outcome. In the event of favorable data from the interim analysis, the FDA has advised that NBTXR3 could potentially qualify for accelerated approval.
In support of the phase III trial and a future NBTXR3 New Drug Application (NDA), Nanobiotix met with the FDA in a Type B end-of-phase I meeting on October 16, 2019. Following additional correspondence with the FDA, including written responses to the FDA’s recommendations, the Company received written FDA guidance on April 3, 2020. The Company expects to commence NANORAY-312 after making protocol refinements and securing the requisite financing to fund the trial.
Agreement to CMC Development Plan
The FDA’s written response regarding the CMC Development Plan does not raise any safety concerns for continued clinical development of NBTXR3, and the FDA agreed to the updated CMC Plan for NBTXR3 during an ongoing phase III clinical trial.
About NBTXR3
NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors.
NBTXR3 is actively being evaluated in clinical trials worldwide as a potential treatment in various cancer indications. The Company is prioritizing the development of NBTXR3 in the United States and the EU for the treatment of patients with locally advanced head and neck cancers ineligible for chemotherapy.
Nanobiotix is also running an Immuno-Oncology development program, evaluating NBTXR3 activated by radiotherapy as a primer of immune response in combination with checkpoint inhibitors. The Company has launched a phase I clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors in patients with locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) amenable to re-irradiation or with lung or liver metastasis (mets) from any primary cancer eligible for anti-PD-1 therapy.
Other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and pancreatic cancer. The Company has a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (initially expected to support nine new clinical trials in the United States) to evaluate NBTXR3 across several cancer types.