NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1

Core Insights - Nanobiotix announced new results from Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors for patients with advanced primary cutaneous melanoma [2][4][5] Study Results - The study involved 21 patients with anti-PD-1 resistant primary cutaneous melanoma, all of whom had advanced disease and had previously undergone multiple lines of therapy [3][5] - A one-time intratumoral injection of JNJ-1900 was administered, followed by radiotherapy and sequential anti-PD-1 therapy [3] - As of the data cutoff on August 21, 2025, 19 patients were evaluable for tumor response, showing a best observed objective response rate (ORR) of 47.4% and a disease control rate (DCR) of 78.9% [5][6] Safety and Efficacy - The treatment demonstrated a favorable safety profile, with 16 patients experiencing treatment-emergent adverse events (TEAEs) related to the overall regimen [6] - The median overall survival (mOS) for all treated patients was reported at 14.6 months [5][6] - A significant relationship was observed between the depth of local response and systemic tumor regression, indicating potential immune response activation [7][8] Future Directions - Investigators concluded that the preliminary data warrant further investigation in randomized clinical trials as a potential new treatment option for patients with primary cutaneous melanoma [5][8] - Nanobiotix plans to host a conference call to discuss the findings on September 18, 2025 [9]