(ChemotherapyAdvisor) – The combination of pertuzumab, trastuzumab, and docetaxel significantly prolonged overall survival (OS) in patients with HER2+ metastatic breast cancer vs trastuzumab plus docetaxel alone, Genentech, a member of the Roche Group and the manufacturer of pertuzumab, announced on June 21 in releasing additional results of the randomized phase 3 CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) study.
The primary outcome results of the global CLEOPATRA demonstrated that pertuzumab, trastuzumab, and docetaxel reduced risk of progression-free survival (PFS) by 38% vs trastuzumab and docetaxel (HR=0.62, P<0.0001). Median PFS was 18.5 months for those in the pertuzumab arm vs 12.4 months for the placebo arm.
These data, reported in the New England Journal of Medicine online December 7, 2011, and in the January 12, 2012 issue, led to the recent U.S. Food and Drug Administration approval of pertuzumab in combination with trastuzumab and docetaxel chemotherapy for the first-line treatment of HER2+ metastatic breast cancer.
The interim analysis of OS, a secondary end point, showed a strong trend in favor of pertuzumab in combination with trastuzumab and docetaxel, Baselga et al. reported. In this analysis, OS crossed the prespecified boundary, the press release stated.
The most common adverse events (>30%) observed in CLEOPATRA for pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia with or without febrile neutropenia, nausea, fatigue, rash and peripheral neuropathy.
Data from this trial will be submitted for presentation at an upcoming medical meeting, Genentech indicted.