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NANOBIOTIX announces positive phase II/III topline data in soft tissue sarcoma with NBTXR3
NANOBIOTIX ANNOUNCES POSITIVE PHASE II/III TOPLINE DATA
Paris, France and Cambridge, Massachusetts, June 21, 2018 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, announced today positive topline results of the Phase II/III act.in.sarc trial evaluating NBTXR3 in Soft Tissue Sarcoma (STS). "Data are exceptional and show without any doubt an improvement of radiation therapy impact with a significant number of complete response. NBTXR3 can bring real benefit to patients and it can change the standard of care. This innovation will play a role in many other indications and particularly where radiotherapy is used alone." NBTXR3 is a first-in-class product with a new mode of action physically destroying cancer cells when activated by radiation therapy. NBTXR3 is designed to directly destroy tumors and activate the immune system for both local control and systemic disease treatment. The Phase II/III study was a prospective, randomized (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 NBTXR3 activated by radiotherapy compared to the standard of care (radiotherapy alone). Patients have been treated with the standard dose of radiation (25x2 Gy) and efficacy endpoints have been measured on surgically resected tumors. Primary endpoint achieved in the intend-to-treat population (ITT) Secondary Endpoint achieved in the ITT - Resection margins status and operability Pr Jean-Yves Blay, MD, Director of the Centre Léon Bérard, Lyon, France, commented, "I am amazed by the difference of Response Rate, it is extremely uncommon to double the Rate of Complete histological Response and I do not see any other strategy able to accomplish that. Even more impressive is the R0 rate, which is increased by more than 20% compared to an average rate of 64%. This difference is really impressive, considering that R0 impacts patients relapses and survival." Safety and feasibility Notably, feasibility and follow-up of surgery were also equivalent. Acute immune adverse events of short duration observed in 7.9% of patients. The Injection site caused pain in 13.5% of patients. In addition, 6.7% of patients experienced grade 1 injection site hematoma / ecchymosis. Regarding long-term toxicity, less serious adverse events were reported for NBTXR3 arm. Regulatory strategy and CE mark Next steps The clinical validation of NBTXR3's physical mode of action in a very heterogeneous and hard-to-treat disease strengthens the universal profile of the product and confirms the development strategy in multiple indications. Currently, the company is evaluating NBTXR3 in seven clinical trials with a focus on head and neck cancers and Immuno-Oncology programs. David Raben MD, Professor of Radiation Oncology, University of Colorado Cancer Center, CO, USA, commented, "These results from a Phase III study are impressive in a notoriously difficult disease like Soft Tissue Sarcoma. These cancers are generally less sensitive to radiation and previous attempts to improve local control with chemo-radiation regimens were considered too toxic. This study substantiates the medical benefit of safely enhancing the effect of radiation therapy with novel physics-based approaches delivered locally within the cancer. In addition, this product may potentiate a pro-inflammatory environment suitable for immune enabling or DNA damage inhibitor drugs. These findings set the foundation for additional studies in areas such as head and neck cancer and perhaps in areas such as high-risk prostate, bladder or pancreas cancer." Webcast and dial-in (English) June 22 at 4pm Paris time: https://origin.yuca.tv/en/nanobiotix/press-conference-2018 For more information about the STS study: www.clinicaltrial.gov (Identifier: NCT02379845) http://www.actinsarc.com/ *** About PII/III clinical trial (act.in.sarc study) Primary endpoint Main secondary endpoint About NBTXR3
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and has the ability to fit into current worldwide standards of radiation care. NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with very limited therapeutic options. The Phase I/II trial has already delivered very promising results regarding the local control of the tumors. Nanobiotix is running an Immuno-Oncology development program . In the U.S., the Company received the FDA's approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer). The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. The first market authorization process (CE Marking) is ongoing in Europe in the soft tissue sarcoma indication. About NANOBIOTIX: www.nanobiotix.com The Nanobiotix philosophy is one rooted in designing pioneer physical based approaches to bring highly effective and generalized solutions to address high unmet medical needs and challenges. The Company's first-in-class, proprietary lead technology, NanoXray, aims to expand radiotherapy benefits for millions of cancer patients. Furthermore, the Company's Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies. Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company's Headquarters are based in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in Spain and Germany. Contact
Disclaimer This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark. |