Genentech Announces Positive Results from a Randomized Phase II Study of Pertuzumab

08-Jan-2007

Genentech, Inc. 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 is believed to play an important role in the growth and formation of several different cancer types.

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, multi-center 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. Patients who had received more than one prior chemotherapy regimen for platinum-resistant disease, or more than one non-platinum-containing regimen for platinum-sensitive disease, were excluded from the study. The primary endpoint of the study was progression-free survival. Exploratory diagnostic marker data to help evaluate if HER2 receptor activation may be a predictor of clinical response were collected as part of this trial, and are currently being analyzed.

https://www.bionity.com/en/news/60568/genentech-announces-positive-results-from-a-randomized-phase-ii-study-of-pertuzumab.html