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EU Approves Bevacizumab Plus Docetaxel for First-Line Metastatic Breast Cancer Treatment

NEW YORK -- July 29, 2009 -- The European Commission has broadened the indication for bevacizumab. Bevacizumab can now be combined with docetaxel for the treatment of metastatic breast cancer.

The approval is based on a phase 3 trial (BO17708) where 736 patients who did not receive previous chemotherapy for their metastatic breast cancer were randomised to bevacizumab 15 mg/kg q3w in combination with docetaxel 100 mg/m²; bevacizumab 7.5 mg/kg q3w in combination with docetaxel 100 mg/m²; or placebo in combination with docetaxel 100 mg/m² (control arm).

The primary objective of the study was to demonstrate superiority in progression free survival (PFS) in 1 or both bevacizumab-containing treatment arms compared with the control arm. Secondary endpoints included response rate, duration of response, time to treatment failure, overall survival, 1-year survival, quality of life, safety, and tolerability.

Based on the updated analysis the combination of bevacizumab and docetaxel resulted in up to 49% increase in PFS when treated with bevacizumab plus docetaxel compared with docetaxel alone.

Over half the patients were alive without their disease progressing for more than 10 months when treated with bevacizumab plus docetaxel.

In the 1-year survival analysis there were significantly more patients alive when treated with bevacizumab plus docetaxel (84%) compared with docetaxel (76%).

Overall survival data, reflecting ~ 45% of events, show no difference between the treatment arms.

No new safety signals, confirming the safety and tolerability profile seen in previous studies. Bevacizumab had only a limited impact on the known toxicity profile of docetaxel.

SOURCE: Roche

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