Genentech announces results from pertuzumab studies on HER2-positive breast cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the company will present results from studies of its investigational medicine pertuzumab in HER2-positive breast cancer at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium December 6-10. This includes data from the first randomized Phase III study of pertuzumab in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy (CLEOPATRA). The mechanisms of action of pertuzumab and Herceptin are believed to complement each other, as both bind to the HER2 receptor but on different regions.

"We are making additional substantial progress against HER2-positive breast cancer, a disease for which we have already dramatically changed the standard of care and improved patient outcomes," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Data at this conference reaffirm our commitment to discovering new treatments for HER2-positive breast cancer."

Data from the VIRGO metastatic breast cancer registry will also be presented. These data emphasize the importance of accurate HER2 diagnostic testing in ensuring that the HER2 status of breast cancer is accurately identified, and that people subsequently receive appropriate treatment for their disease.

Key Study Results to be Presented at SABCS

Pertuzumab

• Full results from CLEOPATRA, a randomized Phase III pivotal study that compared the combination of pertuzumab, Herceptin and docetaxel chemotherapy to Herceptin and chemotherapy alone in people with previously untreated HER2-positive metastatic breast cancer, will be presented by Professor Jose Baselga, M.D., Ph.D., chief of hematology/oncology and associate director of the Massachusetts General Hospital Cancer Center. Pertuzumab is an investigational medicine known as a HER2 dimerization inhibitor (HDI). This is the first time progression-free survival (PFS) data from a randomized study of pertuzumab will be presented, and study results will be featured in a SABCS press briefing.
  
  CLEOPATRA: A Phase III, Randomized, Double-Blind, Placebo-Controlled Registration Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Patients with Previously Untreated HER2-Positive Metastatic Breast Cancer (CLEOPATRA). (Abstract #S5-5). SABCS press briefing, Thursday, December 8, 7:30 a.m. CST. Oral presentation, General Session 5, Friday, December 9, 10:30 a.m. CST, Exhibit Hall D.

• Biomarker analyses from NEOSPHERE, a four-arm randomized Phase II neoadjuvant study evaluating the combination of pertuzumab, Herceptin and chemotherapy in people with newly diagnosed, early-stage HER2-positive breast cancer will be presented by Luca Gianni, M.D., director of medical oncology at the San Raffaele Cancer Center in Milan, Italy. At the 2010 SABCS, the NEOSPHERE data showed giving this combination to people in the neoadjuvant setting significantly improved the rate of complete tumor disappearance (pathological complete response rate, pCR) in the breast by more than half, compared to Herceptin plus chemotherapy without pertuzumab.
  
  NEOSPHERE: Neoadjuvant pertuzumab (P) and trastuzumab (H): Biomarker analyses of a 4-arm randomized Phase II study ('NeoSphere') in patients (pts) with HER2-positive breast cancer (BC). (Abstract #S5-1). Oral presentation, General Session 5, Friday, December 9, 9:30 a.m. CST, Exhibit Hall D.

• Results from TRYPHAENA, a randomized Phase II neoadjuvant study investigating the combination of pertuzumab and Herceptin with or without an anthracycline-based chemotherapy regimen, will be presented by Professor Andreas Schneeweiss, director of gynecological oncology at the National Center for Tumor Diseases, University Hospital Heidelberg, Germany.
  
  TRYPHAENA: Neoadjuvant pertuzumab and trastuzumab concurrent or sequential with an anthracycline-containing regimen or concurrent with an anthracycline-free standard regimen: a randomized Phase II study (TRYPHAENA). (Abstract #S5-6). Oral presentation, General Session 5, Friday, December 9, 10:45 a.m. CST, Exhibit Hall D.

HER2 Testing

• Data from the VIRGO metastatic breast cancer registry will be presented. The results underscore the importance of accurate diagnostic testing, which could potentially impact treatment decisions for many people with breast cancer. Results being presented will specifically address rates of people misdiagnosed with HER2-negative breast cancer.
  
  VIRGO: Discordance between central and local laboratory HER2 testing from a large HER2-negative population in VIRGO, a metastatic breast cancer registry. (Abstract #P1-07-02). Poster Session 1, Prognosis/Response Predictions: Biomarkers - Methods, Wednesday, December 7, 5:00 p.m. CST, Exhibit Halls A-B.