NBTXR3, a first-in-class radioenhancer for pancreatic ductal adenocarcinoma: Report of first patient experience.

BACKGROUND AND PURPOSE

Pancreatic ductal adenocarcinoma (PDAC) remains one of the leading causes of cancer-related deaths in the world. For patients with PDAC who are not eligible for surgery, radiation therapy improves local disease control, yet safely delivering therapeutic doses of radiation remains challenging due to off-target toxicities in surrounding normal tissues. NBTXR3, a novel radioenhancer composed of functionalized hafnium oxide crystalline nanoparticles, has recently shown clinical activity in soft tissue sarcoma, hepatocellular carcinoma, head and neck squamous cell carcinoma, and advanced solid malignancies with lung or liver metastases. Here we report the first patient with pancreatic cancer treated with NBTXR3.

MATERIALS AND METHODS

A 66-year-old male with unresectable locally advanced PDAC was enrolled on our clinical trial to receive NBTXR3 activated by radiation therapy. Local endoscopic delivery of NBTXR3 was followed by intensity modulated radiation therapy (IMRT). Follow-up assessment consisted of physical examination, laboratory studies including CA19-9, and CT of the chest, abdomen, and pelvis.

RESULTS

The patient received NBTXR3 by local endoscopic delivery without any acute adverse events. Radiation treatment consisted of 45 Gy in 15 daily fractions using IMRT. The patient began radiation twelve days after NBTXR3 injection. Daily CT-on-rails imaging demonstrated retention of NBTXR3 within the tumor for the duration of treatment. At initial follow-up evaluation, the lesion remained radiographically stable and the patient did not demonstrate treatment-related toxicity.

CONCLUSION

This report demonstrates initial feasibility of local endoscopic delivery of NBTXR3 activated by radiation therapy for patients with pancreatic cancer who are not eligible for surgery.

Informations de copyright

© 2022 The Authors.

Déclaration de conflit d'intérêts

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: A.M. reports royalties for license from Cosmos Wisdom Biotechnology Ltd. and license for patent from Thrive Earlier Detection, all outside the submitted work. B.D.M. has served as the Co-chair of the Gastrointestinal Steering Committee at the National Cancer Institute (NCI) and has received grants from National Institutes of Health (NIH) and NCI (NIH/NCI 2U19CA021239-35, 1U10CA180858-01), all outside the submitted work. G.L.S. has received grants from NCI, Radiation Oncology Institute, and MD Anderson internal funding, all outside the submitted work. P.D. reports consulting fees from Leidos Biomedical Research, payment for educational events from ASCO, ASTRO, Conveners, and Physicians Education Resource, and participation on an advisory board for Adlai Nortye, all outside the submitted work. A.C.K. reports stock from Aravive, Inc., outside the submitted work. C.M.T. serves on the clinical advisory board for Accuray, Inc., outside the submitted work. E.P.T. reports in kind research funding from General Electric, outside the submitted work. M.S.B. reports institutional research support from Nanobiotix and from Oncosil, Galera, Augmenix, Silenseed, outside the submitted work. E.J.K. reports funding support for the trial from Nanobiotix, and sponsored research funding from Philips Healthcare and GE Healthcare, grant funding from Stand Up 2 Cancer, royalties for book from Taylor and Francis LLC, consulting feeds from RenovoRx, pending patent for 3D-printed oral stents, and a leadership role in International Cholangiocarcinoma Research Network as radiation oncology representative, outside the submitted work. The authors otherwise have no disclosures to report.