Genentech Announces Positive Results From A Randomized Phase II Study Of Pertuzumab In Combination With Gemcitabine For Advanced Ovarian Cancer

Genentech, Inc. (NYSE: DNA) today announced encouraging results from a randomized Phase II study comparing pertuzumab plus gemcitabine to gemcitabine alone in women with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Data from the study will be submitted for presentation at an upcoming medical meeting.

Pertuzumab or 2C4, a humanized antibody formerly known as Omnitarg, is the first in a new class of investigational agents known as HER dimerization inhibitors (HDIs). Pertuzumab is designed to bind to the HER2 receptor - a protein found on the surface of epithelial cells - and inhibit the ability of HER2 to interact with other HER family receptors (HER1, HER2, HER3, and HER4). HER dimerization (pairing) is believed to play an important role in the growth and formation of several different cancer types.

“Advanced ovarian cancer continues to be a difficult-to-treat cancer with few approved treatment options,” said Hal Barron, Genentech senior vice president, Development and chief medical officer. “We are encouraged by the results of this trial, and will continue to analyze the data to help determine next steps for the pertuzumab development program.”

In this study, no new or unexpected safety signals were observed. Adverse events were similar to those observed in previous clinical trials of pertuzumab and included fatigue, diarrhea, back pain, and neutropenia. The cardiac safety profile in the pertuzumab arm was similar to that of the gemcitabine-alone arm; there was one congestive heart failure event reported in the pertuzumab arm. More detailed information about adverse events will be available when the data are presented.

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