AVAiL (BO17704): phase III trial – efficacy of Avastin^© maintained

AVAiL: phase III, randomised, placebo-controlled trial of first-line Avastin^© plus cisplatin/gemcitabine in patients with previously untreated, non-squamous NSCLC

AVAiL: trial design⁸

Reprinted with permission. ©2009 American Society of Clinical Oncology. All rights reserved.

• Phase III, multicentre, randomised placebo-controlled trial of first-line Avastin^© in patients with previously untreated, advanced or recurrent non-squamous NSCLC.⁸
• All patients received six cycles of chemotherapy: cisplatin (80mg/m2) on day 1 and gemcitabine (1,250mg/m2) on days 1 and 8.
• Patients were randomised to receive one of the following (from day 1)
  • Avastin^© 7.5mg/kg every 3 weeks plus chemotherapy until PD (n=345)
  • Avastin^© 15mg/kg every 3 weeks plus chemotherapy until PD (n=351)
  • placebo plus chemotherapy every 3 weeks until PD (n=347).
• The trial was not designed to compare the two Avastin^© doses directly, but to compare each of the Avastin^© doses with placebo.

• Primary endpoint.
  • PFS (Note: the two Avastin^© -containing arms were compared with the chemotherapy only arm and not with each other).
• Secondary endpoints.
  • ORR.
  • duration of response.
  • OS.
  • safety.

AVAiL: Avastin^© -based therapy significantly increases PFS

AVAiL: both doses of Avastin^© significantly increased PFS compared with placebo