Roche Holdings Ltd. (RHHBY) recently reported positive results from a mid-stage study (OAM4558g) of MetMAb, in patients with previously treated advanced non-small cell lung cancer (NSCLC). MetMAb is an investigational antibody designed to target Met, a protein (or receptor) associated with a poor outcome in many cancers.
The study compared MetMAb plus Tarceva (erlotinib) to placebo plus Tarceva in patients with previously treated advanced NSCLC. The study results demonstrated that patients whose tumors had high levels of Met, as determined by a companion diagnostic, lived twice as long without the disease worsening (primary endpoint of the study) when given MetMAb plus Tarceva compared to those who were given only Tarceva.
Roche plans to report full trial data at the Annual Meeting of the American Society of Clinical Oncology (ASCO) scheduled for early June.
We note that Tarceva is currently marketed worldwide as a treatment for advanced NSCLC. The drug faces fierce competition from Eli Lilly & Co.’s (LLY) Alimta, Sanofi-Aventis’ (SNY) Taxotere and AstraZeneca plc’s (AZN) Iressa. Therefore, we note that once MetMAb is approved it will also be facing competition from the same drugs.
Last week, Roche announced the submission of a new drug application (NDA) for its pipeline candidate vemurafenib (RG7204, PLX4032) to the US Food and Drug Administration (FDA). The company is seeking to get the candidate approved for the treatment of patients with BRAF V600 mutation-positive metastatic melanoma (skin cancer).
Roche also submitted a marketing authorization application (MAA) for the drug to the European Medicines Agency (EMA), for the same indication.
The submissions were based on results from two clinical studies – BRIM2 and BRIM3. These studies evaluated vemurafenib in patients with BRAF V600 mutation-positive metastatic melanoma. The disease is determined in patients by the investigational companion diagnostic test, which is also being developed by Roche.
Roche is developing vemurafenib under a license and collaboration agreement with Plexxikon, which was recently acquired by Daiichi Sankyo.
Our Take
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche. We are encouraged by the overall top-line performance of the company despite challenges from a maturing key drug franchise, top-line weakness in the US and Western Europe, as well as an increasing threat from biosimilars.
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
Be the first to comment