Roche/Genentech Report Positive Phase III Results for Her2-Antibody Breast Cancer Therapy
Firms are aiming for regulatory filing later this year.!--h2>
Roche and its Genentech subsidiary reported positive data from a Phase III study combining the antibody candidate pertuzumab with Herceptin® and docetaxel chemotherapy in patients with Her2-postive metastatic breast cancer. Results from the Cleopatra study showed that combination therapy including pertuzumab significantly increased progression-free survival, compared with Herceptin and docetaxel therapy alone. The international two-arm trial enrolled 808 people with previously untreated Her2-positive metastatic breast cancer.
“These results with pertuzumab combined with Herceptin and docetaxel are very encouraging,” comments Hal Barron, M.D., CMO and head of global product development at Genentech. “We plan to submit the study results for global regulatory approval this year.”
Pertuzumab is being evaluated both for the treatment of early-stage and metastatic Her2-positive breast cancer. The monoclonal antibody is a dimerization inhibitor designed to prevent the Her2 receptor from pairing with other HER receptors, and so block cell signaling and inhibit tumor growth or lead to cancer cell death.
Roche believes the mechanisms of pertuzumab and Herceptin are complementary, as the two antibodies bind to different regions of the Her2 receptor. The goal of combining pertuzumab and Herceptin with chemotherapy is to provide a more complete blockage of HER signaling pathways.