French-American biotech company Nanobiotix has achieved positive phase II/III trial results for a nanomedicine designed to help amplify and focus radiation treatment on hard to treat soft tissue sarcoma cells.
The nanomedicine is designed to be injected into the tumour prior to being exposed to radiation via radotherapy. They attach themselves to the tumour cells and allow the tumour, but not the surrounding healthy tissue, to absorb more radiation.
Sylvie Bonvalot, head of the Sarcoma and Complex Tumor Surgery Unit at Institut Curie, Paris said: “Data are exceptional and show without any doubt an improvement of radiation therapy impact,
“This innovation will play a role in many other indications and particularly where radiotherapy is used alone.”
What did the phase II/III trail involve?
NanoBiotix said that the Phase II/III study was a prospective, randomised (1:1), multinational, open label and active controlled two-armed study of 180 patients with locally advanced STS. The objective of the Phase II/III trial was to evaluate the efficacy and the safety of the nanomedicine NBTXR3 activated by radiotherapy compared to the standard of care (radiotherapy alone).
Patients have been treated with the standard dose of radiation and efficacy endpoints have been measured on surgically resected tumours.
As reported by LABIOTECH, overall, 16.1% of participants who received an injection of the nanomedicine achieved a complete response, defined as having 5% or less detectable residual cancer cells. In comparison, only 7.9% of participants who received radiotherapy alone had a complete response.
For those who received surgery to remove their tumours, significantly more patients who received a nanomedicine injection had cancer-free surgical margins after treatment than those who did not.
Nanobiotix is working to use the results from the trial to further its quest for a marketing authorisation in Europe. It is also testing its radioenhancer technology for treatment in a number of other cancers, including head and neck and severe liver cancer, but these trials are at an earlier stage.
Working with nanomedicine
As we have previously reported, nanomedicine use properties developed by a material on a nano-scale; the size offers the potential to cross natural barriers and access new sites of delivery.
Using nanotechnology in healthcare is a key enabling instrument for personalised medicine by delivering the next level of new drugs, treatments and implantable devices to clinicians and patients for breakthroughs in healthcare.