High-Dose BCNU Chemoembolization Yields 93% Disease Control in First-Line Hepatic-Dominant Uveal Melanoma

In the single-arm phase 2 (NCT04728633) trial, 28 treatment-naïve patients with <50% liver involvement and minimal extrahepatic spread received trans-arterial chemo-embolization (TACE) with 300 mg carmustine (BCNU) in ethiodized oil plus gelatin sponge every 4–7 weeks. Median follow-up was 11.6 months. Confirmed overall response rate was 28.6% (8/28 PR); another 18 patients achieved stable disease for a 92.9% disease-control rate. Median liver PFS was 9.9 months and median overall survival 14.1 months; 79% of responders were able to take planned treatment breaks. Grade 3 toxicities were mainly post-embolization pain (18%) and hypertension (14%); transient grade 3–4 transaminase flares occurred in 21%, with no grade 5 events. By contrast, intra-hepatic melphalan perfusion in comparable early-line cohorts reports mPFS ~7 months with ≥grade 3 hepatic AEs in 35%, while systemic tebentafusp delivers a 9% ORR and mOS 21.7 months but is restricted to HLA-A*02:01 patients.