Avastin bevacizumab: Phase II data

Researchers at Hospices Civils de Lyon and colleagues reported data from the open-label, French Phase II METAFORE trial in 24 evaluable patients with HTT showing that Avastin significantly reduced mean cardiac output at 3 months after the first injection, the primary endpoint, to 4.2 L/min/m 2 from 5.01 L/min/m 2 at the start of treatment (p<0.001). At 6 months, Avastin also significantly reduced the endpoint from the start of treatment to 4.06 L/min/m 2. Additionally, Avastin led to a complete response, defined as normalization of cardiac output, in 3 patients and a partial response, defined as any reduction in cardiac index, in 17 patients at 3 months. There were 5 complete responses and 15 partial responses in 23 evaluable patients at 6 months. Furthermore, Avastin significantly reduced the mean duration of epistaxis from 221 minutes/month at baseline to 134 and 43 minutes/month at 3 and 6 months, respectively (p=0.008).

The trial enrolled 25 patients aged 18-70 with confirmed HTT, severe liver involvement and a high cardiac index related to their disease to receive 5 mg/kg Avastin every 14 days for a total of 6 injections. Data were published in the Journal of the American Medical Association. HTT is an inherited genetic vascular disorder that leads to abnormalities of blood vessels. The disease is characterized by recurrent epistaxis, cutaneous telangiectasia and visceral arteriovenous malformations of which liver vascular malformations lead to high output cardiac failure. The only treatment available in severe hepatic forms of HTT to restore normal cardiac output is an orthotopic liver transplant according to the researchers. Genentech said it is not currently evaluating Avastin to treat HTT. ...