Genentech'Perjeta Regimen Extended Lives Of People With Metastatic Breast Cancer

(RTTNews) - Genentech, a member of the Roche Group (RHHBY.PK) said a final data from Phase III Cleopatra study showed that people with previously untreated HER2-positive metastatic breast cancer who received Perjeta or pertuzumab, Herceptin or trastuzumab and docetaxel chemotherapy lived a median of 56.5 months compared to 40.8 months for people who received Herceptin and chemotherapy. However, no new safety signals were observed in the study.

"The median survival of nearly five years for people who received the Perjeta regimen is 15.7 months longer than for people who received Herceptin and chemotherapy alone, a magnitude of improvement we rarely see in clinical trials in advanced cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

Genentech warned that Perjeta may cause heart problems, including those without symptoms, such as reduced heart function, and those with symptoms, such as congestive heart failure. Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy for treatment of breast cancer that has spread to other parts of the body (metastatic) are diarrhea, hair loss, low levels of white blood cells with or without a fever, nausea, feeling tired, rash, and damage to the nerves.

Perjeta in combination with Herceptin and docetaxel chemotherapy is approved in the United States and the European Union for people with previously untreated HER2-positive MBC.

CLinical Evaluation Of Pertuzumab And TRAstuzumab or CLEOPATRA was an international, Phase III, randomized, double-blind, placebo-controlled study. The study compared the combination of Perjeta, Herceptin and docetaxel chemotherapy with placebo, Herceptin and chemotherapy in 808 people with previously untreated HER2-positive MBC, or with HER2-positive MBC that had come back after prior therapy in the adjuvant or neoadjuvant setting.

The primary endpoint of the study was progression-free survival or PFS as assessed by an independent review committee. Secondary endpoints included OS and safety profile.

RHHBY closed Friday's trading at $36.99, down $0.15 or 0.40%, on the OTC markets.