Good results for a phase I/II head and neck cancer trial

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NANOBIOTIX a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, presented the results of the Phase I/II head and neck cancer trial with its lead product candidate, NBTXR3, at the American Society of Clinical Oncology (ASCO), Chicago. Head and neck cancers represent a group of aggressive cancers that appear in the mouth, nose, sinuses and at the top of the aerodigestive tract. This disease is a major public health concern in USA, Europe and Asia. Nanobiotix’s Phase I/II head and neck trial targets frail and elderly patients (more than 70 years) who have advanced stage III/IV cancer with very limited therapeutic options.

The only available treatment for these patients is radiotherapy, as their condition does not allow them to receive a combination of radiotherapy and chemotherapy, which offers a better survival outcome. These patients with radiotherapy treatment alone have a poorer outcome with lower Response Rate, and shorter Overall Survival.

Uncontrolled tumor growth in such population will significantly decrease patients’ Quality of Life because basic functions such as swallowing, breathing, speaking and eating are impaired. NBTXR3 has demonstrated an excellent safety profile, with no Adverse Events (serious or not) related to the product.The radiotherapy safety observed in the trial has been strictly the same to the IMRT well-known toxicity. This is an important finding, given the elderly and frail population treated in this trial. Additionally, the injection was demonstrated to be feasible and appropriate as the product remained in the tumor from the first day until the last day of radiotherapy. Marginal passage in the blood circulation has been observed during injection time. No leakage in the surrounding tissues have been observed. The highest dose (22%) continues to be evaluated. The Overall Response Rate (Partial Response plus Complete Response) was evaluated as per RECIST 1.1. The first data showed promising signs of antitumor activity.

The Overall Response Rate is 91% (10 out of 11 patients evaluable) and 7 out 9 patients (78%) had Complete Reponse at 10% dose level or more. In addition, the tumor response suggests a dose dependent effect (see figure below: waterfall plot). So far, all of the patients treated at higher dose levels (15% and 22%) have shown a prolongated Response with no loco-regional or distant relapse, with a medium follow up of 12 months. Looking at the future, Nanobiotix is filing a protocol amendment of this study to include 44 additional patients in an expansion to demonstrate the efficacy of NBTXR3. Nanobiotix is opening 12-15 additional sites in Europe to expand the development of this indication. The company plans to expand this study in the US.

 

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