ARTICLE | Clinical News

Roche discontinues NSCLC trial of onartuzumab

March 4, 2014 1:58 AM UTC

Roche (SIX:ROG; OTCQX:RHHBY) discontinued the Phase III METLung trial evaluating IV MetMAb onartuzumab plus Tarceva erlotinib as a second- or third-line treatment for metastatic non-small cell lung cancer (NSCLC) patients with MET-positive tumors. The move came after top-line data from a pre-specified interim analysis by an independent DMC showed a "lack of clinically meaningful efficacy." The double-blind, placebo-controlled trial enrolled 499 previously treated NSCLC patients. Roche said it is conducting further analysis to determine next steps across all indications for the monovalent mAb against c-Met proto-oncogene (MET; HGFR).

In July, Roche's Genentech Inc. unit disclosed that it discontinued development of onartuzumab as first- and second-line treatment of triple-negative metastatic breast cancer after the product missed the primary endpoint of improving progression-free survival (PFS) in a Phase II trial. Roche also discontinued a Phase II trial evaluating the compound for glioblastoma after the trial missed its primary PFS endpoint. Onartuzumab is still in Phase III testing for metastatic, HER2-negative gastric cancer and Phase II testing for metastatic colorectal cancer and first-line squamous and non-squamous NSCLC. ...