TAbS







Onartuzumab Terminated Naked monospecific

Antibody Information

Entry ID 2398
INN Onartuzumab
Status Terminated
Drug code(s) PRO143966, RG3638, RO5490258
Brand name MetMAb
mAb sequence source mAb humanized
General Molecular Category Naked monospecific
Format, general category Fragment-Fc
Format details Fab-Fc
Isotype (Fc) IgG1
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) cMET
Indications of clinical studies Non-Small Cell Lung Cancer, Glioblastoma, Gastric Cancer, Colorectal Cancer, Breast 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) February 15, 2007
Start of Phase 2 April 15, 2009
Start of Phase 3 July 15, 2011
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 Genentech
Licensee/Partner None
Comments about company or candidate NCT02488330 Phase 3 extension study in solid tumors active not recruiting as of July 2016. Two Phase 3 (NCT01887886 and NCT02031744) studies in NSCLC still recruiting as of April 8, 2015. Study in triple negative breast cancer terminated in July 2013; Phase 3 study in NSC lung cancer terminated for lack of clinically meaningful efficacy in March 2014. Removed from Roche pipeline for liver cancer (Phase 1), colorectal cancer (Phase 2) and gastric cancer (Phase 3) as of pipeline update July 24, 2014.
Full address of company South San Francisco, California, United States
North America
United States of America
https://www.gene.com/contact-us/visit-us

Description/comment

Monovalent; target cMet (aka hepatocyte growth factor receptor)

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None