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Nanobiotix SA (EPA:NANO) unveiled some promising data from the recent phase I/II head and neck cancer trial of its lead candidate, NBTXR3, at the American Society of Clinical Oncology (ASCO) in Chicago over the weekend. The early-stage study was designed to ensure the safety and feasibility of the product, which it duly did. NBTXR3 demonstrated an “excellent safety profile” the company said, with no adverse events, serious or not, related to the treatment. On top of that, the injection was shown to be “feasible and appropriate” with the product remaining in the tumour throughout the period of radiation treatment. 91% overall response rate, 78% complete response rate As well as looking at the primary safety and feasibility endpoints, Nanobiotix also had a couple of exploratory endpoints – efficacy and patient outcome – which, although not the focus at this stage, it set out to study. The overall response rate to the product was 91%, while seven out of nine patients who had a dose level of 10% or more had a complete response to NBTXR3. Most of the complete responses occurred between three and ten months after the end of the treatment, during the follow-up when patients weren’t receiving any oncology treatments. So far, Nanobiotix said, all of the patients treated with the higher doses (between 15% and 22%) have shown a prolonged response with no relapse during the 12 months after treatment. As you can see from the picture in the tweet below, the trial yielded tangible, promising signs of antitumor activity. Encouraging results for Nanobiotix's head/ neck/cancer treatment. 7/9 patients had a complete response (i.e. tumour gone) at 10+% dose level pic.twitter.com/tHUdxR77iR — Tom Howard (@proactivetom) June 6, 2017 Before investors go too overboard, there are a couple of caveats to add to the results. It must be remembered that the patient group was only small, and a complete response doesn’t necessarily mean the cancer has been ‘cured’, it just means that all signs of the cancer, at least temporarily, have disappeared. “The very good level of tolerance seen so far, the absence of adverse events related to the product, and the rate of complete response in this population, indicates that NBTXR3 could play a key role in the treatment of head and neck cancer,” said chief medical officer Elsa Borghi. “It could potentially have a direct impact on the patients’ outcome via loco-regional control, quality of life, safety and overall survival.” Next steps for NBTXR3 As mentioned above, this early-stage study involved only a handful of patients. To get a proper understanding of how effective the product is in the real world, it needs to be tested on more people. Understandably then, Nanobiotix is set to file for a protocol amendment of the study which will include an additional 44 patients, with plans to expand the trial into the US. The company hopes that it will achieve similar results with a larger patient population, giving more credibility to the data and further demonstrating the efficacy of NBTXR3.NEXT ARTICLE
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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