US FDA clears restart of Roche Ph III Avastin trials; other strong data presented at San Antonio meeting

The US Food and Drug Administration is permitting Swiss drug major Roche to resume enrolment in a Phase III trial evaluating its monoclonal antibody Avastin (bevacizumab) in early-stage HER2-negative breast cancer, reports Reuters.

Enrolment in the trial was temporarily suspended on September 25, because six cases of clinical congestive heart failure (CHF) were reported during a pre-planned cardio-toxicity analysis of the first 200 patients. Global cancer drug leader Roche said that the study's data safety monitoring board had concluded that the risk-benefit assessment of Avastin in combination with anthracycline, cyclophosphamide and paclitaxel chemotherapy in this trial remained unchanged.

More trial data presented at San Antonio Breast Cancer Symposium

Over the weekend, meantime, Roche announced positive results from a Phase II study of trastuzumab-DM1 at the 32nd Annual San Antonio Breast Cancer Symposium, demonstrating that T-DM1 shrank the tumors in 33% of women with advanced HER2-positive breast cancer that had worsened following previous treatment. The subjects in the study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1. No new or unexpected safety signals were observed.

Also, the company presented new long-term follow up-data from two large pivotal studies - N9831 and BCIRG006 evaluating adjuvant Herceptin (trastuzumab) in HER2-positive early stage breast cancer at the Symposium suggesting that the drug reduced the risk of the cancer relapse by one third compared to patients receiving chemotherapy alone. In both studies, at least 80% of women receiving one year of Herceptin experienced free of disease at 5 years follow-up.

Additionally, Roche announced results from a Phase III RIBBON 2 study of Avastin in women with advanced HER2-negative breast cancer who had previously received chemotherapy as first-line treatment. The study demonstrated that Avastin improved progression-free survival by 28% compared to chemotherapy alone (HR = 0.78, p=0.0072). Avastin plus chemotherapy had a median PFS of 7.2 months versus 5.1 months for those who received chemotherapy alone. The observed response rate in tumor shrinkage was 39.5% vs 29.6% for Avastin + chemotherapy vs chemotherapy alone, p=0.0193, thus further supporting the activity of Avastin in this setting.