* Positive phase III data for Perjeta compared to placebo
* Data shows Perjeta combination reduces risk of death by 34
* Perjeta already approved in U.S., submitted in EU
ZURICH, Dec 8 Swiss pharma group Roche's
drug Perjeta significantly extended the lives of women
with an aggressive and incurable form of breast cancer compared
to a placebo, according to new data from a late-stage study
presented on Saturday.
The detailed data presented at the San Antonio Breast Cancer
Symposium found that the risk of death was reduced by 34 percent
in women treated with a combination treatment of the drugs
Perjeta and Herceptin plus chemotherapy compared to women
treated with Herceptin, chemotherapy and a placebo, Roche said.
Roche is hoping that the Perjeta combination will become the
standard treatment for women with a form of cancer known as
HER2-positive, which makes up about a quarter of all breast
cancers and has no cure.
At the time of the analysis, median overall survival had not
yet been reached in people receiving the Perjeta combination, as
more than half of these people continued to survive, Roche said.
Median overall survival was more than three years for people
who received Herceptin and chemotherapy, Roche said, adding no
new safety signals had been observed in the phase III study.
"This treatment combination with Perjeta is the first to
have significantly extended survival compared to Herceptin and
chemotherapy in people with previously untreated HER2-positive
metastatic breast cancer," Roche's Chief Medical Officer Hal
Barron said in the statement.
Breast cancer is the most common cancer among women
worldwide, with about 1.4 million new cases diagnosed each year
and more than 450,000 women dying of the disease annually,
according to the World Health Organisation.
Perjeta, also known as pertuzumab, is a personalised
medicine that targets a protein found in high quantities on the
outside of cancer cells in HER2-positive cancers.
It was granted approval by U.S. health regulators in June.
Roche is awaiting a decision from European regulators.
Vontobel analyst Andrew Weiss forecasts peak sales of 2
billion Swiss francs ($2.15 billion) for the drug.
Roche is also developing an "armed antibody" known as TDM-1
as a treatment for HER2-positive breast cancer. TDM-1 combines
Herceptin with a derivative of a powerful type of chemotherapy
and is designed to reduce unpleasant side effects.