Roche to share Avastin data from trial to determine benefits to glioblastoma patients

Roche Holding AG and a group of outside investigators might agree on sharing raw data from conflicting trials of Avastin (bevacizumab) to help determine whether brain cancer patients had really benefited from the drug.

According to a Bloomberg report, the data is drawn from two trials that both found the drug did not help patients with glioblastoma live longer, but found a difference in a more subjective measure - quality of life. According to results published yesterday in the New England Journal of Medicine, researchers who led a Roche-sponsored trial said Avastin improved or maintained quality of life and brain function as against an independent study that found Avastin patients were worse off on both counts.

The outcome might help determine a broad user for the drug in glioblastoma, a cancer whose patients had few other options for treatment. Basel, Switzerland-based Roche, had received accelerated approval for Avastin in glioblastoma in 2009 based on earlier, smaller trials.

The drug, which notched up sales of 6.25 billion Swiss francs last year, is also used in the treatment of metastatic colorectal and kidney cancers and tumours.

The difference between the studies is ''neither trivial nor academic,'' Howard Fine, deputy director of the New York University Cancer Institute, wrote in an editorial published with the results. If Avastin improves 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.''

Avastin works against cancer by preventing the creation of new blood vessels that provide the tumor with nutrients and oxygen.

The US Food and Drug Administration has approved the use of Avastin's in combination with standard chemotherapy in the treatment some forms of colon, lung, kidney, ovarian and breast cancer and had also been approved to treat recurring glioblastoma.