Nanobiotix announces new data from Study 1100

Nanobiotix announced new data from Study 1100, a U.S. Phase 1 dose escalation and dose expansion study evaluating radiotherapy-activated NBTXR3 followed by anti-PD-1 immune checkpoint inhibitors as a second-or-later line therapy for patients with advanced solid and metastatic tumors. These data were presented at the 2024 Annual Meeting of the American Society for Clinical Oncology. At the data cutoff, NBTXR3 injection followed by standard RT and anti-PD-1 therapy was feasible and well tolerated in 68 heavily pretreated patients with 2L+ R/M-HNSCC. Serious Grade 3+ adverse events related to the combined therapeutic regimen occurred in 8.8% of patients. Investigators concluded that promising early signals of efficacy were observed in Study 1100 patients with naive or resistant 2L+ R/M-HNSCC who received RT-activated NBTXR3 followed by anti-PD-1. Disease control was observed in both naive and resistant R/M-HNSCC patients, highlighting the potential for NBTXR3 in this population. Overall, these results warrant further exploration in randomized trials for both naive and resistant R/M-HNSCC patients. Nanobiotix expects to provide first data from cohort 3 of the Study 1100 dose expansion part in 2025.