Roche racks up another PhIII setback as MetMab flops against lung cancer

More than two years ago Roche ($RHHBY) CEO Severin Schwan picked the cancer drug MetMab out of the pipeline as one of the company's top blockbuster prospects. But on Monday its oncology R&D arm at Genentech was forced to halt a Phase III combo study matching MetMab with Tarceva in a failed effort to block metastasis in non-small cell lung cancer after an independent monitoring group flagged the attempt for futility.

MetMab (onartuzumab) was aimed straight at the Met pathway, with investigators expecting to see further signs that the drug could throw a monkey wrench in a biologic cascade that triggers the spread of cancer as cells grow, divide and spread. The late-stage study was designed to determine if the combination approach could allow advanced patients to live longer.

Woburn, MA-based ArQule ($ARQL) and Daiichi Sankyo tried the same approach with their Met inhibitor tivantinib, only to announce last fall that their late-stage effort failed to improve survival time for NSCLC. Back-to-back failures on the same pathway raise serious questions about the future of Met inhibition, at least in lung cancer, a hard target in the oncology world.

"These results are disappointing because new options are needed for people with lung cancer, the most common and deadly cancer worldwide," said Dr. Sandra Horning, chief medical officer and head of global product development, in a statement. A total of 499 patients were randomized to either get the drug combo or Tarceva matched with a placebo.

Roche says it plans to review the data before deciding its next step on MetMab.

The failure follows fast on the heels of another signal defeat in late-stage studies for Roche. The schizophrenia drug bitopertin failed a Phase III trial, marking the latest in a series of setbacks for the difficult field.

Roche has been undergoing a major overhaul of its R&D operations in recent years. Its Basel-based pRED group has been refilling its pipeline over the last year after shuttering a sprawling research campus in Nutley, NJ. And gRED (Genentech) in California has been continuing its hunt for new drugs, which has delivered a series of pioneering approvals.  

- here's the press release

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