Roche may open Avastin data to sort out conflicting brain-cancer studies

Should Avastin really join the small set of tools in the brain-cancer toolbox? With studies offering conflicting results, Roche and some outside researchers may share data to answer that question.

In one trial, published Thursday in the New England Journal of Medicine, the Swiss drugmaker's treatment for colon and other cancers didn't improve overall survival in patients with glioblastoma, a type of brain tumor that's very difficult to treat. But Avastin did improve quality of life and brain function. In another trial, dubbed RTOG 0825, Avastin came up empty on all three measures.

So, as Bloomberg reports, Roche ($RHHBY), which sponsored the first trial, may share its data with the investigators in the other trial. The idea is to determine whether the differences in outcome arose from statistical methods or some other source.

In an NEJM editorial, the New York Cancer Institute's Howard Fine explained the need to sort out the differences in the two studies. If Avastin does really improve patients' quality of life and brain function, "then a strong argument can be made for its use as part of the initial treatment of glioblastoma, regardless of its effect on survival," Fine wrote (as quoted by Bloomberg).

Fine wasn't involved in either of the two contradictory studies, but he has studied Avastin in brain cancer, and he explained to Bloomberg that cognitive function declines as brain tumors progress. Slowing that decline could make a big difference to patients, even if they don't end up living longer than they otherwise would.

Roche recently rolled out a new policy on sharing data from clinical trials, after years of pressure from outsiders such as the Cochrane Group and the BMJ (formerly the British Medical Journal). The company told Bloomberg that it's already talking to the investigators in the RTOG trial and other parties about sharing its data on Avastin in brain cancer.

Meanwhile, Roche won approval last year in Japan for Avastin as a first-line treatment for brain cancer, including glioblastoma. It's regrouping on a similar application in Europe after a key committee recommended against its use in brain cancer. In the U.S., Avastin is approved to treat brain cancer patients whose disease has progressed after prior treatment, and it has been since 2009. It's also approved for a host of other indications in the U.S. and elsewhere, including colorectal and lung cancers, and it last year won European approval in ovarian cancer.

- read the Bloomberg news

Related Articles:
Roche follows GSK in move to open its data vault
Roche scores first-line brain cancer use for Avastin in Japan
ASCO: Bayer's Nexavar gets boost, while Roche's Avastin reports mixed

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