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

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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