Nanobiotix announced Hensify (NBTXR3) has obtained a CE mark for the treatment of locally-advanced soft tissue sarcoma. Hensify is the brand name for NBTXR3 as approved for the treatment of locally-advanced STS.
Hensify was designed by Nanobiotix to physically destroy tumor and activate the immune system for both local control and systemic disease treatment when combined with radiation therapy. In addition to Hensify, NBTXR3 is currently under evaluation in various other indications such as lung cancer, head and neck cancers, liver cancer, and prostate cancer.
Hensify is an aqueous suspension of crystalline hafnium oxide nanoparticles designed for injection directly into a tumor prior to a patient’s first standard radiotherapy treatment. When exposed to ionizing radiation, Hensify amplifies the localized, intratumor killing effect of that radiation.
The dose of X-ray delivered to the tumor is magnified, whilst the dose passing through healthy tissues remains unchanged. Hensify requires a single administration and will fit into current worldwide standards of radiation care.
STSs are rare cancers that develop in different types of soft tissues including fat, muscles, joint structures and blood vessels. Radiotherapy followed by surgery is part of the typical treatment regimen for STS patients in Europe.
The Act.In.Sarc phase II/III trial was a prospective, randomized (1:1), multinational, open label and active controlled two armed trial of 180 adult patients with locally advanced STS of the extremity or trunk wall. The objective of the trial was to evaluate the pre-operative efficacy and the safety of Hensify activated by radiotherapy compared to the standard of care (radiotherapy alone).
The positive Act.In.Sarc study results were presented at the 2018 ASTRO and ESMO Annual Congresses. The trial achieved its primary endpoint with a pathological complete response (<5% viable cancer cells) rate of 16.1% in the Hensify arm compared to 7.9% in the control arm (p=0.0448).
In addition, in the subgroup of patients with a more aggressive disease (histologic grade 2 and 3), a pathological complete response was achieved in four times as many patients in the Hensify® arm as in the control arm (17.1% compared 3.9%).
Similar safety profiles were observed in the Hensify arm and the radiation therapy alone control arm. Hensify did not impair the patients’ ability to receive the planned dose of radiotherapy and the radiotherapy safety profile was similar in both arms, including the rate of postsurgical wound complications.
Post-approval trials are planned across Europe and discussions on next steps regarding potential further development are ongoing.
