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Genentech/Roche: new breast cancer trial sparks hope for Avastin

Genentech/Roche's Avastin has met its primary endpoint in a second Phase III breast cancer study.

Avastin has met its primary endpoint of progression-free survival in a Phase III breast cancer trial. However, an FDA committee recommended against its approval in December 2007, following the review of a previous Phase III study in this indication. The new trial data supports Avastin's therapeutic potential, and may influence the FDA's final approval decision expected later this month.

The second Phase III multicenter trial, AVADO, in HER2-negative metastatic breast cancer, met its primary goal of prolonging progression-free survival in previously untreated patients. In this study, 736 patients were randomized to receive Avastin (15mg/kg or 7.5mg/kg) or placebo with 100mg/m2 Taxotere (docetaxel; Sanofi-Aventis) every three weeks for up to nine cycles, after which patients received Avastin or placebo until the first event of disease progression or death. No new safety concerns were raised in this second trial and Avastin showed potential for combination with Taxotere.

Genentech/Roche's anti-angiogenic monoclonal antibody Avastin (bevacizumab) is currently under FDA review following submission of a supplemental biologics license application (sBLA) for its use in combination with paclitaxel in the first-line treatment of HER2-negative locally advanced recurrent or metastatic breast cancer patients.

Avastin received a negative opinion from the Oncologics Drugs Advisory Committee in December 2007, which voted five-to-four in favor of recommending against approval when data from a pivotal study failed to show an overall survival benefit in any of the 722 patients enrolled. In this trial, first-line Avastin in combination with paclitaxel extended progression-free survival by five and a half months, but increased the likelihood of serious side effects by 20%.

Avastin, which is marketed by Genentech in the US and Roche in the EU, was initially approved by the FDA and EMEA for the treatment of metastatic colorectal cancer in February 2004 and March 2005 respectively. It also gained approval for NSCLC in the US (October 2006) and renal cell carcinoma in the EU (December 2007) as a first-line therapy. In March 2007, Avastin was approved in the EU for the first-line treatment of metastatic breast cancer in combination with the standard chemotherapy paclitaxel.

The AVADO trial data has been shared with the FDA to assist its assessment of the benefit and risk of Avastin in HER2-negative metastatic breast cancer patients. Although the drug is already used off-label in the US for metastatic breast cancer, FDA approval would allow Avastin to be promoted for this indication and potentially secure reimbursement from insurers. If approval is granted, Avastin is expected to be added to existing first-line treatment options for metastatic breast cancer patients.

Related Research:

• Pipeline Insight: Breast Cancer - Recent approvals increase pressure on pipeline candidates

[edit] Sources

• Datamonitor