* Avastin halves risk of ovarian cancer progression
* Positive survival trend seen in newly-diagnosed patients
By Deena Beasley
CHICAGO, June 4 (Reuters) - Avastin, the multibillion-dollar cancer drug sold by Roche ROG.VX, helps slow the progression of ovarian cancer, according to new studies.
But the question of whether it lengthens the lives of women with the disease remains unanswered, although researchers reported a trend toward improved survival in newly-diagnosed patients.
The issue of Avastin’s usefulness has become controversial in the wake of trials showing that it does not extend overall survival for women with metastatic breast cancer.
Results from two trials of Avastin -- one in patients with recurrent ovarian cancer and another in newly-diagnosed women -- were presented here on Saturday at a meeting of the American Society of Clinical Oncology.
Patients with recurrent disease had a 52 percent reduction in the risk of cancer progression when treated with Avastin and chemotherapy, compared to treatment with chemotherapy alone.
Median progression-free survival was 12.4 months for Avastin patients, compared to 8.4 months for patients on just chemotherapy, according to researchers.
Side effects, such as high blood pressure, were in line with those seen in previous studies, although there were no gastrointestinal perforations, which had been a concern raised in earlier ovarian cancer trials.
The trial of 1,528 newly-diagnosed women found that 28 months after treatment, there were fewer deaths in the Avastin group (178) than in the standard therapy group (200), but the difference was not statistically significant.
Researchers said that for women with more advanced cancers, and thus at highest risk of recurrence, Avastin produced a more robust 36 percent reduction in the risk of death.
“As long as there is at least a trend for an overall survival advantage ... I think that that should lead to approval in front-line and second-line therapy,” said Dr. Robert Burger, director of Fox Chase’s Women’s Cancer Center and a previous Avastin investigator.
The drug, also known as bevacizumab, had sales of $6.5 billion Swiss francs ($7.8 billion) last year. Analysts, on average, have projected 2015 sales of just over $7 billion, according to Thomson Pharma.
Avastin -- an antibody designed to cut off blood supply to tumors -- is used to treat several different kinds of cancers including colorectal and lung, but regulators have questioned approval of the drug as a treatment for women with metastatic breast cancer.
The U.S. Food and Drug Administration has scheduled hearings on the issue later this month.
“Progression-free survival is a surrogate for other measures, such as living longer or quality of life,” said Philippe Bishop, head of Avastin clinical development at Roche’s Genentech unit. “The consequence of not being able to control the disease is ultimately to face a death sentence.”
A course of treatment with Avastin is priced at about $58,000.
Bishop said Roche has filed for European approval of Avastin as a front-line treatment for ovarian cancer and expects a decision sometime before the end of the year.
In the United States, the company is talking with regulators and plans to file for approval of the new indication before the end of this year.
According to the American Cancer Society, in 2010 an estimated 21,880 U.S. women were diagnosed with ovarian cancer, most with advanced disease, and around 13,850 died from the cancer. (Reporting by Deena Beasley; Editing by Vicki Allen)