Nanobiotix Presents Successful Phase I Results for NBTXR3
Nanobiotix announced the successful completion of the first in human study of its lead NanoXray product, NBTXR3. The Phase I clinical study established that intratumoral injection of NBTXR3 followed by radiotherapy has a good safety profile in patients with locally advanced soft tissue sarcoma (STS), who have an important risk of relapse and few treatment options. These results allow Nanobiotix to proceed to the pivotal phase, which is the final step leading to registration (CE mark).
The study showed that promising signs of antitumor activity for different sarcoma subtypes were observed. Interestingly, tumor shrinkage and pathological response were observed in well-known refractory tumors. All patients underwent a wide surgical resection. This optimal surgery impacts the local recurrence rate, improving patient prognosis since local disease control prolongs progression free survival and overall survival in high grade sarcomas.
The study enrolled 20 patients who received a single intratumoral injection of NBTXR3, at escalating volumes, followed by standard radiotherapy (50Gy RTx), as indicated in this clinical setting.
Primary endpoints included feasibility of the intratumoral implantation and safety. Secondary endpoints focused on the efficacy such as pathological response and RECIST (Response Evaluation Criteria In Solid Tumors) response, including tumor volume evaluation. Moreover, IntraTumoral permanence of NBTXR3 and operability were assessed.
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