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 |
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 |
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 | 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/ |
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/
Anticipated events | None |
Factor(s) contributing to discontinuation | Safety |