NANOBIOTIX has announced updates to the Company’s global development plan for first-in-class radioenhancer NBTXR3 at the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting.
While the COVID-19 crisis and subsequent measures to curtail the spread of the virus have created challenges in clinical trial recruitment, a sharpened focus on the Company’s priority pathways in head and neck cancer and immunotherapy has led to the continued achievement of necessary milestones for the development of lead product candidate NBTXR3. Moreover, diligent efforts in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) in the United States (US) has helped to advance expansion of the development plan across new indications.
Priority Development in Head and Neck Cancer and Immunotherapy
Pathway to Global Registration in Head and Neck Cancer On Track
Nanobiotix has presented an update on the expansion part of the Company’s phase I study evaluating NBTXR3 activated by radiation therapy for patients with head and neck cancer (Study 102) at ASTRO 2020. In 31 evaluable patients, positive results confirmed the target lesion objective response rate presented earlier this year at 83.9% and showed an increase in target lesion complete response rate at 67.7%. The target lesion complete response rate is an increase over previously reported data (60%) with additional follow up (7.8-month median follow up vs. 5 months). Additionally, data showed an overall objective response rate of 83.9% and an overall complete response rate of 48.4%, which were also increases over previously reported data (83% and 43% respectively).
The trial has recruited 44 patients in total (31 evaluable to date), and will remain ongoing until reaching 44 evaluable patients. The next update on the study is expected in the second quarter of 2021.
Preparation for the Company’s pivotal phase III trial evaluating NBTXR3 activated by radiation therapy for patients with head and neck cancer (NANORAY-312) is ongoing as planned. The trial is expected to commence after the financing to fund the trial is secured.
As previously announced, NBTXR3 activated by radiation therapy for the population in NANORAY-312 received Fast Track designation from the US Food and Drug Administration (FDA) in February 2020. Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.
First Clinical Data in Immunotherapy to be Presented in Coming Weeks
Nanobiotix will present the first clinical results from a phase I study evaluating NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab for patients with head and neck cancer, lung metastasis and/or liver metastasis (Study 1100) by the end of 2020.
Nine patients have been injected in the trial thus far and recruitment remains ongoing. After the release of first results, the next step for the trial will be establishment of the recommended phase II dose (RP2D) by mid year 2021 for the head and neck cancer cohort and the lung metastasis cohort, and in the second half of 2021 for the liver metastasis cohort.
Early-Stage Development Across Other Solid Tumor Indications and with Collaborators
Nanobiotix Trials in Additional Solid Tumor Indications
The dose escalation part of the Company’s phase I/II trial evaluating NBTXR3 activated by radiation therapy for the treatment of patients with hepatocellular carcinoma (HCC) or liver metastasis (Study 103) has completed successfully and final data has been presented at ASTRO 2020. Data showed that the product candidate continues to be safe and well tolerated with no dose-limiting toxicities (DLTs). Early efficacy data showed a target lesion objective response rate of 90.9% in evaluable patients with hepatocellular carcinoma (HCC) and a target lesion objective response rate of 71.4% in evaluable patients with liver metastasis. Further development in this indication will proceed after the launch of the Company’s phase III head and neck cancer trial.
The Company’s phase I trial evaluating NBTXR3 activated by radiation therapy for the treatment of patients with prostate cancer (Study 104) has administered NBTXR3 to five patients, with no serious adverse events and no DLTs reported. At present the Company has paused development in this indication to focus resources on the head and neck cancer and immunotherapy pathways.
In soft tissue sarcoma, the final patient follow up visit has been completed in the phase III Act.In.Sarc study. The planned post-registrational trial is expected to launch in 2021.
Trials with Collaborators
The Company’s clinical collaboration with MD Anderson continues to move forward with the launch of a phase I trial evaluating NBTXR3 activated by radiation therapy for patients with pancreatic cancer. FDA ‘Safe to Proceed’ notifications have been received for four additional trials in the collaboration and are pending activation.Back To Top
ASTRO 20: NANOBIOTIX Updates Global Clinical Development Plan for Radioenhancer NBTXR3. Appl Rad Oncol.