Drug intelligence / Profile preview

ivonescimab + gemcitabine + cisplatin

Development stage
Phase 3
Lead developer
Akeso
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

Ivonescimab + gemcitabine + cisplatin is an investigational combination regimen consisting of ivonescimab, a first-in-class PD-1/VEGF bispecific monoclonal antibody, co-administered with the standard chemotherapy doublet gemcitabine (a nucleoside analog) and cisplatin (a platinum-containing alkylating agent). This combination is primarily developed as a first-line treatment for patients with unresectable locally advanced or metastatic biliary tract cancer (BTC). Ivonescimab simultaneously blocks the PD-1/PD-L1 immune checkpoint pathway and VEGF-A-mediated angiogenesis, while gemcitabine and cisplatin provide synergistic cytotoxic tumor cell destruction by inhibiting DNA synthesis and inducing DNA damage. In the Phase III HARMONi-GI1 trial, this regimen demonstrated a statistically significant and clinically meaningful overall survival benefit compared to the standard-of-care durvalumab plus gemcitabine and cisplatin.

Other names
AK112 + gemcitabine + cisplatinAK112 plus gemcitabine and cisplatinAK-112 plus gemcitabine and cisplatinAK 112 plus gemcitabine and cisplatinSMT112 + gemcitabine + cisplatinSMT112 plus gemcitabine and cisplatinSMT-112 plus gemcitabine and cisplatinSMT 112 plus gemcitabine and cisplatinivonescimab + GemCisivonescimab plus GemCisivonescimab plus gemcitabine and cisplatinivonescimab plus gemcitabine plus cisplatin
02

Targets

DNAPDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)PDCD1LG2 (Programmed cell death 1 ligand 2)RNR (Ribonucleotide reductase)VEGFA (Vascular endothelial growth factor A)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)

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