Roche will seek approval later this year for its investigational breast cancer drug pertuzumab, based on encouraging results of a late-stage trial.
The Swiss major says the Phase III CLEOPATRA study showed that people with HER2-positive metastatic breast cancer who received the combination of pertuzumab and Herceptin(trastuzumab), plus docetaxel chemotherapy lived significantly longer without their disease getting worse (ie progression-free survival) than people who received a Herceptin/docetaxel combination.
Roche noted that no new safety signals were observed and adverse events were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone. The full data set from CLEOPATRA, which involved 808 patients, will be submitted for presentation at an upcoming medical meeting.
Chief medical officer Hal Barron said that the results with pertuzumab combined with Herceptin and docetaxel are very encouraging "and represent our commitment to developing potential new personalised options for people with this aggressive disease".