23 Mar 2017

NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the local treatment of cancer, today announced that the Independent Data Monitoring Committee (IDMC) has completed the interim evaluation of the Phase II/III trial results (Act.In.Sarc) of NBTXR3 in soft tissue sarcoma.
The interim evaluation was based on an analysis of the results of two-thirds of the patients included in the Phase II/III study – 104 patients were analyzed out of a total of 156. Based on the safety and available efficacy data, the IDMC has recommended the continuation of the Phase II/III trial of NBTXR3 in soft tissue sarcoma.

“The IDMC’s recommendation to continue the ongoing phase II/III trial of NBTXR3 is very positive news for soft tissue sarcoma patients, and an important milestone in NBTXR3’s clinical development.” said Elsa Borghi, Nanobiotix’s Chief Medical Officer “Now, we look forward to seeing the full data analysis” she added.
The pivotal international Phase II/III study in soft tissue sarcoma was launched in Europe and Asia in October 2014 and aims to evaluate the safety and the efficacy of NBTXR3, a first in-class radio enhancer that could potentially target most solid tumors. The Phase II/III study is a prospective, randomized, multi-center, open label and active controlled two-armed study of 156 patients with locally advanced soft tissue sarcoma. The primary endpoint is the complete pathological response rate. The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the evaluation of the safety profile in term of clinical and laboratory adverse events; the tumor volume changes; the resection margins and the limb amputation rate.

The IDMC is an international independent body of experts made up of scientists, statisticians and practicing physicians. Specifically, it was chartered to review and ensure: i) the data related to the primary endpoint, ii) the safety of all patients enrolled in the study, (iii) the quality of the data collected, and (iv) the continued scientific validity of the study design on two thirds of the patients treated.
The completion of recruitment for the Act.in.Sarc trial is planned by the end of Q2 2017. The full data analysis, except for long-term follow-up, is expected to be available at the end of 2017.
Based on the positive recommendation from the IDMC, the Company will communicate, over the coming weeks, its overall plan to move forward.