IDMC recommends continuation of the Phase II/III trial of NBTXR3

Nanobiotix, a late-stage clinical nanomedicine company, has announced that the Independent Data Monitoring Committee (IDMC) has completed the interim evaluation of the Phase II/III trial results 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 study — 104 out of the 156 patients were analysed. Based on the safety and available efficacy data, the IDMC recommended that the trial be continued.

“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.”

Launched in Europe and Asia in October 2014, the Phase II/III study in soft tissue sarcoma aims to evaluate the efficacy and safety of NBTXR3, a radio enhancer that could potentially target most solid tumours. It is a randomized, prospective, multicenter, 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 tumour volume changes, the resection margins and the limb amputation rate.