TAbS







Rilotumumab Terminated Naked monospecific

Antibody Information

Entry ID 1815
INN Rilotumumab
Status Terminated
Drug code(s) AMG 102
Brand name None
mAb sequence source mAb human
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG2
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology Transgenic mouse (Xenomouse)-derived

Therapeutic information

Target(s) HGF
Indications of clinical studies Glioma, Glioblastoma Multiforme, Non-Small-Cell Lung cancer, Renal Cell Carcinoma, Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Prostate Cancer, Small Cell Lung Cancer, Colorectal Cancer
Primary therapeutic area Cancer

Development stage information


Most advanced stage of development (global) Terminated at Phase 3
Status Inactive
Start of clinical phase (IND filing or first Phase 1) December 16, 2004
Start of Phase 2 November 15, 2006
Start of Phase 3 October 15, 2012
Date BLA/NDA submitted to FDA
Year of first approval (global) None
Date of first US approval
INN, US product name None
US or EU approved indications None

Company information

Company Amgen
Licensee/Partner None
Comments about company or candidate Amgen has discontinued development of rilotumumab, a fully-human MAb that inhibits hepatocyte growth/scatter factor and c-met, for the treatment of cancer, following a safety review by the RILOMET-1 independent data monitoring committee found an increase in the number of deaths in the rilotumumab and chemotherapy treatment arm when compared to the chemotherapy treatment only arm Phase 1/2 with Amgen as collaborator ongoing as of Feb 2016. Partnership with Astellas for marketing in Japan. Failed in Phase 3 in gastric cancer
Full address of company Thousand Oaks, California, United States
North America
United States of America
https://www.amgen.com/

Description/comment

Oct 2007 publication: AMG 102, a fully human monoclonal antibody that binds to hepatocyte growth factor (HGF), is a potential cancer therapeutic agent because of its ability to disrupt HGF/c-Met signaling pathways which have been implicated in most tumor types. To support a phase 1 study, the pharmacokinetic and safety profile of AMG 102 was assessed in cynomolgus monkeys. https://pubmed.ncbi.nlm.nih.gov/17520181/

Additional information

Anticipated events None
Factor(s) contributing to discontinuation Safety