Nanobiotix Announces Publication of Phase III Soft Tissue Sarcoma Data for First-in-class NBTXR3 in the Lancet Oncology

NANOBIOTIX公司晚期软组织肉瘤治疗药物NBTXR3达III期试验主要终点

2019-07-11 19:00:00 BioSpace

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Previously reported data from the registration study in advanced Soft Tissue Sarcoma patients demonstrated a significant advantage in both pathological complete response and rate of margin-negative resection for those treated with NBTXR3 activated by standard of care radiation therapy versus RT alone Data showed that an increase in efficacy was achieved with the addition of NBTXR3 without a significant difference in the safety profile compared to RT alone The trial validates the clinical application of the mode of action of this new class of treatment, which supports further investigation in a larger field of indications “Act.In.Sarc results published in The Lancet Oncology show clear superiority of NBTXR3 activated by radiation therapy versus radiation alone as evidenced by the significant increase in complete response. As I have stated previously, NBTXR3 is an innovation that could bring real benefits to patients and change the standard of care. It is an honor to have this potential recognized by our scientific peers.” – Pr. Sylvie Bonvalot, MD, PhD, Head of Sarcoma and Complex Tumor Surgery at the Curie Institute and Global Principal Investigator of the Act.In.Sarc Study. “The data published in The Lancet Oncology represent another important moment for our company, our partners, and our patients. As members of the global scientific community we have a responsibility to make positive and substantial contributions to our field. Achievement of first European market approval provided validation for our contribution from a regulatory perspective, but recognition from our peers is especially rewarding.” – Edwina Baskin-Bey, MD, Chief Medical Officer of Nanobiotix. NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the previously reported results from the Phase II/III Act.In.Sarc trial evaluating NBTXR3 in patients with advanced STS 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 NBTXR3 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 NBTXR3 activated by RT was similar to RT alone, with manageable and reversible transient immune reactions observed in those treated with NBTXR3 and RT. More detail on the results can be found here. The data from the Act.In Sarc trial were the basis for first European market approval (CE marking) of NBTXR3 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 NBTXR3 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 NBTXR3 in combination with immune-oncology agents.
先前报告的数据来自于先进的软组织 Sarcoma 患者的注册研究表明,在病理完全反应和边缘负切率的优势,治疗 NBTXR3激活的标准治疗放射治疗相对 RT 单独 数据显示,与单纯 RT 相比,NBTXR3在安全性方面没有显著差异,从而提高了疗效。 该试验验证了这一新型治疗方法的临床应用,为进一步研究更大范围的适应症提供了依据 “法案。在。《柳叶刀肿瘤学》发表的 Sarc 研究结果显示,放疗激活的 NBTXR3与单纯放疗相比具有明显的优越性,完全缓解的显著增加就证明了这一点。正如我之前所说的, NBTXR3是一种创新,可以为患者带来真正的利益,并改变护理标准。让我们的科学同行认识到这一潜力是一项荣誉。”– Pr 。Sylvie Bonvalot 博士,Curie 研究所 Sarcoma 和复杂肿瘤外科主任兼该法全球首席调查人。在。Sarc 研究。 “发表在《柳叶刀肿瘤学》上的数据对我们的公司、我们的合作伙伴和我们的患者来说是另一个重要时刻。作为全球科学界的成员,我们有责任为我们的领域作出积极和实质性的贡献。首次获得欧洲市场批准,从监管角度验证了我们的贡献,但同行的认可尤其有益。”– Edwina Baskin-Bey ,医学博士,纳米生物的首席医疗官。 ANOBIOTIX ( Euronext : NANO-ISIN : FR0011342105),一家临床阶段的纳米制药公司,开创了新的癌症治疗方法,今天宣布,先前报告的结果,第二/三期法案。在。在《柳叶刀肿瘤学》上发表了评估晚期 STS 患者 NBTXR3的 Sarc 试验。 注册研究满足其主要终点( pCR )和次要终点( R0速率)。与单纯 RT 相比,在给予 NBTXR3作为标准治疗前单次注射的患者中, pCR 的比例增加(大约是前者的两倍),为纳米颗粒增强肿瘤细胞死亡的有效性提供了有力的理由。RT 激活的 NBTXR3的总体安全性与 RT 单独相似,在NBTXR3和 RT 治疗的患者中观察到可控和可逆的瞬态免疫反应。 该法的数据。在Sarc试验中, NBTXR3首次获得欧洲市场批准( CE 标志)的基础是先进的极端 STS 和胸壁,品牌为Hensify ®。随着 STS 结果验证产品的疗效和安全性,公司将继续发展战略,在多个全球(美国、欧盟和 APAC )临床试验中评估 NBTXR3,重点包括但不限于:头颈部、肝脏、肺和前列腺癌。以及可能受益于 NBTXR3结合免疫肿瘤药物的肿瘤。

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