ZURICH (Reuters) - Swiss drugmaker Roche Holding AG said its "armed antibody" T-DM1 drug significantly extended the lives of women with an aggressive type of breast cancer compared to those receiving the standard drug cocktail.
Breast cancer, the most common cancer among women worldwide, will afflict about 1.4 million women worldwide and more than 450,000 women will die of the disease annually, according to the World Health Organization's International Agency for Research on Cancer.
Roche said its Genentech unit will soon submit a marketing application to the European Medicines Agency for trastuzumab emtansine (T-DM1) and has already applied for a license with the U.S. Food and Drug Administration.
Roche said the EMILIA study of the drug had now met both primary efficacy endpoints of significant improvements in overall survival and progression-free survival, adding it will present the data at an upcoming medical meeting.
Roche, the world's largest maker of cancer drugs, has been developing T-DM1 as a successor to its blockbuster Herceptin, its third-biggest seller, which could be exposed to so-called "biosimilar" generic competition in Europe from around 2015.
The trial for women with breast cancer known as HER-2 positive - which makes up about a fifth of all breast cancers - compared T-DM1 to the combination of GlaxoSmithKline drug, Tykerb, and Roche's, Xeloda.
An advantage of T-DM1 over conventional treatment using Herceptin plus chemotherapy, is that it causes fewer adverse side effects like hair loss and low white blood cell counts.
T-DM1 combines trastuzumab, an antibody and the active ingredient in Herceptin, with the agent DM1 - a derivative of a powerful type of chemotherapy called maytansine - which is carried directly into cells.
"We believe that antibody-drug conjugates have the potential to change the future treatment of cancer," Roche Chief Medical Officer Hal Barron said in a statement.
In June, U.S. health regulators approved Perjeta, another new breast cancer drug from Roche for HER2-positive women.
Genentech, which developed Perjeta, suffered a blow last year when the FDA revoked approval for its blockbuster drug Avastin as a treatment for breast cancer, saying the drug was not effective enough to justify its risks.
(Reporting by Emma Thomasson; Editing by Matt Driskill)