Roche to file for approval of pertuzumab, which does well as combo in Ph III breast cancer trial

Swiss drug major Roche (ROG: SIX) says it plans to seek approval of its monoclonal antibody pertuzumab from health authorities based on encouraging results in the treatment of breast cancer.

Roche announced that CLEOPATRA, a pivotal Phase III study, met its primary endpoint. The study showed that people with HER2-positive metastatic breast cancer (mBC) who received the combination of two targeted medicines, pertuzumab and the company’s blockbuster drug Herceptin (trastuzumab), plus docetaxel chemotherapy lived significantly longer without their disease getting worse (progression-free survival, PFS) than people who received only Herceptin and docetaxel.

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. Data from CLEOPATRA will be submitted for presentation at an upcoming medical meeting. Despite significant progress, HER2-positive metastatic breast cancer remains an incurable disease, the company noted.