* Avastin halves risk of ovarian cancer progression
* Positive survival trend seen in newly-diagnosed patients
By Deena Beasley
CHICAGO, June 4 Avastin, the
multibillion-dollar cancer drug sold by Roche ROG.VX, helps
slow the progression of ovarian cancer, according to new
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
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.
CUTS OFF BLOOD SUPPLY
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
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
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
(Reporting by Deena Beasley; Editing by Vicki Allen)