Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Kadcyla ® (ado-trastuzumab emtansine) significantly extended the time people with advanced HER2-positive breast cancer (metastatic and unresectable locally advanced/recurrent) lived without their disease worsening (progression-free survival [PFS], a co-primary endpoint) compared to people who received a treatment of their physician’s choice in an open-label Phase III study called TH3RESA. The data showed the risk of disease worsening or death was reduced by 47 percent for people who received Kadcyla (HR=0.528, p<0.0001). Data for overall survival, the other co-primary endpoint, are not yet mature. No new safety signals were observed with Kadcyla.
The study enrolled people with advanced HER2-positive breast cancer who had progressed despite prior treatment with at least two HER2-targeted medicines. It randomized people to receive either treatment with Kadcyla or a treatment of their physician’s choice. Eighty percent of people treated with physician’s choice received a regimen containing Herceptin ® (trastuzumab).
“The TH3RESA study is the second large Phase III study in which Kadcyla has improved the amount of time patients with an advanced form of HER2-positive breast cancer lived without their tumor growing,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are pleased that the data from multiple clinical trials reinforces Kadcyla’s benefit for people with this aggressive disease.”
The late-breaking TH3RESA data will be presented tomorrow at the European Cancer Congress (ECC), by Dr. Hans Wildiers, University Hospital Leuven, Gasthuisberg, Belgium (Abstract #LBA15, Saturday, September 28, 2013 at 1:03 p.m. CEST). The data are also part of the official press program.In February 2013, Kadcyla was approved by the U.S. Food and Drug Administration for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. Kadcyla recently received a positive opinion from the European Union’s Committee for Medicinal Products for Human Use (CHMP) as a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin and a taxane, separately or in combination. A European Commission decision on EU marketing approval is expected by the end of the year.