Genentech Announces Positive Results From a Randomized Phase II Study of Pertuzumab in Combination With Gemcitabine for Advanced Ovarian Cancer

Update: Perjeta (pertuzumab) Now FDA Approved - June 8, 2012

SOUTH SAN FRANCISCO, Calif., January 04, 2007 /PRNewswire-FirstCall/ -- Genentech, Inc. 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.

About the Study

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.

About Pertuzumab

Pertuzumab is a humanized monoclonal antibody designed to bind to the HER2 receptor and inhibit the ability of HER2 to interact with other HER family members (HER1, HER2, HER3, and HER4). The HER signaling pathway plays a role in the formation and growth of numerous cancers, and previous clinical trials of pertuzumab in a single agent setting had suggested clinical activity - including stable disease - in heavily pretreated patients with advanced ovarian and breast cancers. Genentech and Roche are evaluating pertuzumab in solid tumors (ovarian and breast cancers), and in combination with other therapies. Diagnostic analyses to evaluate if HER2 receptor activation may be a predictor of clinical response, with the goal of helping oncologists select patients most likely to respond to pertuzumab, are a component of all ongoing pertuzumab clinical trials.

About Ovarian Cancer

The American Cancer Society (ACS) estimates that in 2006, approximately 20,180 women will have been diagnosed with ovarian cancer and 15,310 will have died of the disease. Ovarian cancer is the eighth most common cancer among women, and is the fifth most common cause of cancer death among women. According to the ACS, fallopian tube cancer and primary peritoneal cancers often are grouped with the ovarian cancer category of tumors, as symptoms and treatment are similar.

About Genentech BioOncology

Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is conducting clinical development programs for Rituxan(R) (Rituximab), Herceptin(R) (Trastuzumab), Avastin(R) (bevacizumab), and Tarceva(R) (erlotinib), and markets all four products in the United States, either alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan), or OSI Pharmaceuticals, Inc. (Tarceva).

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell death), the HER pathway, and B-cell biology. An investigational antibody directed at the HER pathway is currently in Phase II trials. In early development, are a small molecule directed at the hedgehog pathway and an investigational agent targeting apoptosis.

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com .

Contact: Krysta Pellegrino, +1-650-225-8226, or Investors, Diane Schrick, +1-650-225-1599, or Advocacy, Kristin Reed, +1-650-467-9831.

CONTACT: Krysta Pellegrino, +1-650-225-8226, or Investors, Diane Schrick,+1-650-225-1599, or Advocacy, Kristin Reed, +1-650-467-9831

Web site: http://www.gene.com/

Ticker Symbol: (NYSE:DNA)

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Posted: January 2007

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