Setback for Roche

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Roche (RHHBY) recently suffered a setback when it announced that an independent data monitoring committee has recommended that its phase III study, METLung, on oncology candidate onartuzumab (MetMab) should be stopped due to lack of clinically meaningful efficacy.

Shares were down 4.38% on the news. The study evaluated the impact of onartuzumab in combination with Tarceva in extending the life span of patients with previously treated, advanced non-small cell lung cancer (:NSCLC) vis-à-vis only Tarceva. These patients had MET+ tumors.

The interim data analysis showed that the overall adverse event rates were generally similar between the two groups. The detailed data from the study will be presented later.

Consequently, Roche is evaluating the implications of the METLung study results to decide on the future development of onartuzumab.

As per estimates from the World Health Organization, NSCLC accounts for 85% of all lung cancers.

We note that Tarceva was one of the top selling drugs of Roche in 2013, generating sales of $1.3 billion, up 4% from a year ago. Hence, the results from the phase III study were disappointing as the successful development of onartuzumab would have boosted Roche’s strong portfolio of oncology drugs.

We note that onartuzumab is also being evaluated for the treatment of metastatic HER2-negative gastric cancer (currently in phase III), first line non-squamous non-small cell lung cancer and squamous non-small cell lung cancer (both in phase II) and metastatic colorectal cancer (currently in phase II) among others.

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma industry include Novo Nordisk (NVO), Auxilium Pharmaceuticals (AUXL) and Forest Laboratories (FRX). While Auxilium Pharma is a Zacks Rank #1 (Strong Buy) stock, the other two carry a Zacks Rank #2 (Buy).

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