Phase 3 trial of anlotinib versus dacarbazine for advanced or metastatic synovial sarcoma

Anlotinib is a novel, orally administered, small molecule tyrosine kinase inhibitor. The phase 3 APROMISS study, in the United States and Italy, randomized patients with advanced or metastatic synovial sarcoma to anlotinib or dacarbazine. The progression-free survival was 2.89 months with anlotinib versus 1.64 months with dacarbazine (HR 0.449; p=0.0015). Grade 3 treatment-emergent adverse events were reported for 23% of patients with anlotinib versus 26% of patients with dacarbazine.