1554TiP A randomized phase II study to investigate the efficacy and safety of the tumor-targeting human antibody-cytokine fusion protein L19TNF in previously treated patients with advanced or metastatic soft tissue sarcoma

Abstract

Although tumor necrosis factor (TNF) is one of the most potent antitumor cytokines, its unacceptable toxicities do not allow for systemic administration of therapeutically active doses. L19TNF is a fully human antibody-cytokine fusion protein, composed of the neovascular targeting antibody fragment scFv(L19) fused to human recombinant TNF, that selectively delivers therapeutically relevant doses of TNF to the tumor tissue while sparing normal tissues. L19TNF has demonstrated substantial therapeutic activity in preclinical models of sarcoma when administered alone or in combination with chemotherapy, leading to hemorrhagic tumor necrosis and immune-mediated tumor rejection.