Advanced | Nano Publications https://bibliography.nanobiotix.com/fr/ Navigate through all Nanobiotix publications online Tue, 24 May 2022 16:11:09 +0000 fr-FR hourly 1 https://wordpress.org/?v=6.0 https://bibliography.nanobiotix.com/wp-content/uploads/2019/11/cropped-n-icon-512x512-32x32.png Advanced | Nano Publications https://bibliography.nanobiotix.com/fr/ 32 32 2018 – OncoRad – NBXTR3 in HNSCC and NSCLC with anti-PD1 https://bibliography.nanobiotix.com/fr/2018-oncorad-nbxtr3-in-hnscc-and-nsclc-with-anti-pd1/ Fri, 05 Oct 2018 08:58:04 +0000 http://bibliography.nanobiotix.com/__trashed/ Recent clinical studies have demonstrated the efficacy of anti-PD-1 in recurrent/metastatic HNSCC and upfront metastatic NSCLC patients. However, most patients with recurrent/metastatic HNSCC demon-strate innate (primary) resistance to checkpoint inhibition and do not respond to initial therapy and only a subset of metastatic HNSCC/NSCLC patients benefits from this treatment. […]

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Authors

Seiwert T.1, Le Tourneau C.2, Paris S.3, Bonvalot S.2

1 – The University of Chicago Medicine, Chicago (IL), USA
2 – Institut Curie, Paris, France
3 – Nanobiotix, Paris, France

Summary

Recent clinical studies have demonstrated the efficacy of anti-PD-1 in recurrent/metastatic HNSCC and upfront metastatic NSCLC patients. However, most patients with recurrent/metastatic HNSCC demonstrate innate (primary) resistance to checkpoint inhibition and do not respond to initial therapy and only a subset of metastatic HNSCC/NSCLC patients benefits from this treatment. There is thus an important unmet medical need for a curative treatment of this population. We hypothesized that intra-tumoral/intralesional injection of NBXTR3 in the tumor or in one metastasis in lung or liver, followed by SABR may be a powerful mechanism to convert the local immune microenvironment to a “hot” phenotype and thus help to reverse resistance to immune checkpoint inhibition.

We thus designed an open label Phase I/II, non-randomized clinical study of NBTXR3 activated by SABR in combination with approved anti-PD1 in patients with advanced HNSCC or NSCLC. The primary objective of the phase I is to determine the maximum tolerated dose/s, the early DLTs and the recom-mended dose/s of NBTXR3. The primary objectives of the phase II part are complete response of target lesion/s by RECIST v1.1 for the locoregional recurrent group, objective Response Rate by RECIST v 1.1 for the metastatic group and incidence of adverse events in both groups with a complete safety as-sessment.

The post 2018 – OncoRad – NBXTR3 in HNSCC and NSCLC with anti-PD1 first appeared on Nano Publications.]]> 2018 – ASTRO 2018 – Phase III NBTXR3 in Soft Tissue Sarcoma https://bibliography.nanobiotix.com/fr/2018-astro-2018-phase-iii-nbtxr3-in-soft-tissue-sarcoma/ Wed, 31 Oct 2018 07:49:43 +0000 http://bibliography.nanobiotix.com/?p=1651 A subset of soft tissue sarcoma (STS) patients achieve significant therapeutic benefit from preoperative radiotherapy (RT). Yet, this treatment paradigm may be associated with limited efficacy and increased toxicity, highlighting the necessity of novel multimodal therapies aimed at local control with few adverse events (AEs). NBTXR3 is a first-in-class Hafnium-Oxide nanoparticle. […]

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Authors

S. Bonvalot1, P. Rutkowski2, J. O. Thariat3, S. Carrere4, M. P. Sunyach5, E. Saada7, P. Ágoston7, A. Hong8, A. Mervoyer9, M. Rastrelli10, C. Le Pechoux11, V. Moreno12, R. Li13, B. Tiangco14, A. Casado15, A. Gronchi16, L. C. Mangel17, P. Hohenberger18, M. Delannes19, Z. Papai20

1 – Institut Curie, Paris, France
2 – Centrum Onkologii-Instytut im. Sklodowskiej-Curie w Warszawie, Warszawa, Poland
3 – Centre Baclesse, Caen, France
4 – Montpellier Cancer Institute, Montpellier, France
5 – Centre Leon Berard, Lyon, France
6 – Centre Antoine Lacassagne, Nice, France
7 – National Institute of Oncology, Budapest, Hungary
8 – Chris O’Brien Lifehouse, Camperdown, Australia
9 – Institut de Cancerologie de l’Ouest-Rene Gauducheau, Saint-Herblain, France
10 – Istituto Oncologico Veneto IRCCS, Padova, Italy
11 – Institut Gustave Roussy, Villejuif, France
12 – Hospital Fundación Jimenez Diaz, Madrid, Spain
13 – St. Luke’s Medical Center, Quezon City, Philippines
14 – The Medical City Cancer Center, Pasay City, Philippines
15 – Hospital Clinico Universitario San Carlos, Madrid, Spain
16 – Istituto Nazionale Tumori, Milan, Italy
17 – Pecs University, Pecs, Hungary
18 – Universitätsklinikum Mannheim, Mannheim, Germany
19 – Institut Claudius Regaud, Toulouse, France
20 – Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary

Summary

A subset of soft tissue sarcoma (STS) patients achieve significant therapeutic benefit from preoperative radiotherapy (RT). Yet, this treatment paradigm may be associated with limited efficacy and increased toxicity, highlighting the necessity of novel multimodal therapies aimed at local control with few adverse events (AEs). NBTXR3 is a first-in-class Hafnium-Oxide nanoparticle. Designed for cancer cell uptake, it is injected intratumorally (IT) and activated by ionizing radiation to yield a tumor-localized high energy deposit and increased cell death compared to the same dose of RT alone. We report now the first phase II/III randomized clinical trial of NBTXR3 given as preoperative treatment to patients with locally advanced STS of the extremity and trunk wall.

This trial met its primary and secondary endpoints of pCRR and R0 rates, respectively. NBTXR3 with RT demonstrated an acceptable safety profile compared to RT alone. As pCR is a known indicator of long-term treatment response with a positive correlation to both progression free and overall survival, NBTXR3 represent a new option for preoperative treatment for locally advanced STS.

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