NANOBIOTIX announced updated data from the company’s Phase 1 immunotherapy study, Study 1100. These data will be presented at the 37th Annual Meeting of the Society for Cancer Immunotherapy (SITC). Radiotherapy Activated NBTXR3 in Combination with Nivolumab or Pembrolizumab in Patients with Advanced Cancer: Results of an Ongoing Phase I Dose Enhancement Study u Abstract # 684.
Updated data summary: Reported data included 28 patients, 21 of whom had been validated for the first signs of efficacy at the time of data cut-off on 22 August 2022. Treatment remained feasible and well tolerated, with a profile of safety consistent with expectation of strotactic body radiotherapy (SBRT; RT) followed by anti-PD-1 immune checkpoint inhibitors. An objective reduction from baseline in target lesions (objective reduction) was observed in 71.43% of the patients evaluated (15/21).
42.86% of the patients evaluated (9/21) showed an objective reduction greater than 30%. 71.43% of patients evaluated (15/21) had cancer resistant to previous anti-PD-1 exposure and tumor regression was observed in 66.66% of these patients (10/15). At the time of closure of the data, systemic disease control was lasting and maintained for more than 6 months in 38.10% of patients evaluated (8/21).
A delayed objective reduction was observed in several patients, suggesting the potential for antitumor immune activity over time. The recommended phase 2 dose (RP2D) of RT-activated NBTXR3 followed by anti-PD-1 was established at 33% of the gross tumor volume in the 3 cohorts at the end of the dose escalation portion of Study 1100. Dose extension of the study is ongoing in the United States, with a modified protocol for robust evaluation of RT-activated NBTXR3 plus anti-PD-1 in patients with recurrent locorgial squamous cell carcinoma (LRR) or recurrent head and / or metastatic (R / M) and neck (HNSCC) that is naive or resistant to previous exposure to anti-PD-1.
The Company plans to submit a Phase 3 registration protocol for the evaluation of NBTXR3 activated with RT plus anti-PD-1 in patients with anti-PD-1 resistant LRR or HNSCC R / M 1 The U.S. Food and Drug Administration in first quarter 2023.