NANOBIOTIX ESTABLISHES RECOMMENDED DOSE FOR REGISTRATION STUDY EVALUATING NBTXR3 + ANTI-PD-1 COMBINATION IN PATIENTS WITH METASTATIC HEAD AND NECK CANCER AND IMMUNOTHERAPY RESISTANT – 09/21/2022 at 22 :20


• Recommended dose for phase 2 of the dose escalation part of study 1100, established at 33% of the tumor volume (GTV) in the three cohorts of the study.
• Updated clinical data from Study 1100 are expected in Q4 2022.
• Submission to the US Food and Drug Administration (FDA) of the Phase 3 protocol evaluating NBTXR3 in combination with an anti-PD-1 for patients with head and neck cancer is scheduled for the first quarter of 2023.

Paris, France ; Cambridge, Massachusetts (USA); September 21, 2022– NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the “Company”), a late-stage biotechnology company pioneering physics-based approaches to expand treatment options for cancer patients, announces today that it has established the recommended dose for the phase 2 (RP2D) of the study combining NBTXR3 with pembrolizumab or nivolumab in the treatment of head and neck squamous cell carcinoma (HNSCC) locoregional recurrent (LRR) or recurrent and metastatic (R/M) inoperable and resistant to immunotherapy. RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab in patients with: LRR or R/M HNSCC who had not received prior immunotherapy, lung or liver metastases from any primary tumor .



Source link -86