Data from Pharmawand - Curated by EPG Health - Date added 11 July 2019
Nanobiotix announced that the previously reported results from the Phase II/III Act.In.Sarc trial evaluating NBTXR 3 in patients with advanced Soft Tissue Sarcomas have been published online in The Lancet Oncology. The registration study met its primary (pCR) and secondary (R0 rate) endpoints. The increased proportion of patients with pCR among those given NBTXR 3 as a single injection prior to standard of care RT when compared to RT alone (approximately twice as many), provides robust justification for the efficacy of nanoparticle-enhanced tumor cell death. The overall safety profile of NBTXR 3 activated by RT was similar to RT alone, with manageable and reversible transient immune reactions observed in those treated with NBTXR3 and RT.
The data from the Act.In Sarc trial were the basis for first European market approval (CE marking) of NBTXR 3 in advanced STS of the extremity and chest wall, under the brand name Hensify. With STS results validating the efficacy and safety profile of the product, the company will continue its development strategy to evaluate NBTXR 3 in multiple global (US, EU and APAC) clinical trials with a focus including but not limited to: head and neck, liver, lung and prostate cancer, as well as tumors that may benefit from NBTXR 3 in combination with immune-oncology agents.
See: "NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2–3, randomised, controlled trial." Sylvie Bonvalot et al. Lancet Oncology Published:July 08, 2019 DOI: https://doi.org/10.1016/S1470-2045(19)30326-2