Metronomic gemcitabine/doxorubicin/docetaxel + PD-1 nivolumab posts 57% ORR and 9.4-mo PFS in advanced angiosarcoma

Metronomic GDD plus nivolumab is a dose-dense chemo–immunotherapy regimen combining cytotoxics (gemcitabine, doxorubicin, docetaxel) with PD-1 blockade (nivolumab), evaluated in a Phase II study in advanced angiosarcoma (NCT04535713) in a heavily variable pretreated population (median 1 prior regimen; range 0–9). In the modified ITT cohort with ≥2 cycles and imaging (n=7 evaluable of 9 treated), median PFS was 9.4 months (95% CI: 8.224–9.441) with 1 CR, 3 PR, 3 SD (ORR 57%; DCR 100%); in the ITT cohort (n=9), median OS was 28.4 months (95% CI: 0.724–31.217). Safety was intensive: 89% had ≥Grade 3 TRAEs, dominated by cytopenias (e.g., leukopenia 6/9, neutropenia 5/9, thrombocytopenia 4/9), plus single cases of decreased LVEF and hypothyroidism; there were no Grade 5 or unexpected events—efficacy looks better than typical single-agent anthracycline or weekly paclitaxel benchmarks where median PFS is ~4–5 months, though with a notably higher Grade 3+ AE burden here than weekly paclitaxel series typically report