The Unmet Need
Out of the approximately 890,000 new head and neck patients worldwide each year, 70 - 80% will receive radiation therapy. There remains, however, significant unmet medical needs regarding either local control, systemic control, toxicity, or some combination of the three. This is especially challenging for patients ineligible for platinum-based chemotherapy (cisplatin).
As part of our commitment to improve treatment outcomes for cancer patients, we expanded our focus to head and neck cancers.
Following proof-of-concept and European market approval for NBTXR3 in locally advanced soft tissue sarcoma of the extremities and trunk wall, we are prioritizing our registration pathway in the US and EU for the treatment of head and neck cancers.
NBTXR3 nanoparticles activated by intensity-modulated radiation therapy (IMRT) showed promising early signs of efficacy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC), in our Phase I dose escalation/does expansion trials. The patient population includes elderly and frail patients who are ineligible for cisplatin or intolerant to cetuximab.
In 2019, we began interacting with the US Food and Drug Administration (FDA) on its regulatory pathway, to fine-tune the design elements of our Phase III dual-arm, investigator’s choice, randomized (1:1) global registration trial including elderly head and neck cancer patients who are ineligible for platinum-based chemotherapy (cisplatin).
At the start of 2020, we announced our head and neck Phase III registration trial. Subsequently, we were granted Fast Track designation by U.S. FDA for investigation in head and neck cancer.
From Our Experts
Hear from our leading medical experts on how the innovative work in NBTXR3 could provide benefits for locally advanced head and neck cancer patients that are ineligible for cisplatin.
NBTXR3 Intratumoral Injection
“Intratumoral injection of NBTXR3 is feasible and safe and NBTXR3 remains localized within the tumor throughout RT treatment.”
Head & Neck cancer phase I trial
“Radiotherapy is the only option to treat this fragile H&N Cancer population and benefits are limited.”
“Changing the treatment paradigm for millions of patients by bringing nanophysics to the heart of the cell.”