GENENTECH RELEASES RESULTS FROM OVARIAN CANCER STUDY

Genentech has announced 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.

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. HER dimerization (pairing) is believed to play an important role in the growth and formation of several different cancer types, according to the company.

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.

In this Phase II, placebo-controlled, double-blinded, multicenter study, 130 women with advanced ovarian, primary peritoneal or fallopian tube cancer were enrolled and received treatment with pertuzumab plus gemcitabine, or gemcitabine alone. Eligible patients must have experienced disease progression within six months of receiving a platinum-based chemotherapy regimen that did not contain gemcitabine or any other HER receptor targeting agent. The primary endpoint was progression-free survival.