Nanobiotix (NANO) Study Result summary

Study background and patient population

• Phase 1 trial evaluated NBTXR3 (JNJ-1900) with SBRT and immune checkpoint inhibitors in patients with advanced, anti-PD-1 resistant melanoma who had failed multiple prior therapies, including anti-CTLA4 and other systemic agents.

• 21 patients were enrolled, median age 63, with 19 evaluable for efficacy; most had stage III/IV disease.

• All patients had received anti-PD-1 therapy, and many had also received anti-CTLA4, T-VEC, TIL, or radiotherapy.

• Patients had exhausted available therapeutic options, highlighting a highly resistant population.

Safety and tolerability

• NBTXR3 injection at 33% gross tumor volume was feasible and well tolerated, with no grade 4 or 5 adverse events or serious adverse events related to the product or injection.

• Most common adverse events included fatigue (38.1%), diarrhea (23.8%), and nausea (19.0%).

• Grade 3+ treatment-related adverse events occurred in 4.8% of patients; one patient had grade 3 hypertension and pleuritic pain not linked to the injection procedure.

• Safety profile was consistent with previous studies and other cohorts.

Efficacy and clinical outcomes

• Objective response rate (ORR) was 47.4% (9/19), including 4 complete and 5 partial responses; disease control rate (DCR) was 78.9% (15/19).

• 100% DCR was observed in injected lesions.

• Median overall survival was 14.6 months (CI: 11.6 to not reached), exceeding historical benchmarks for this population.

• Median time to progression-free survival was 6.3 months.

• Responses were observed regardless of the number or type of prior treatments, and even patients with 5+ lesions had an 80% DCR.