“People with newly diagnosed glioblastoma have few treatment options and need new medicines,” said Hal Barron M.D., chief medical officer and head of Global Product Development. “An important outcome from the AVAglio study was that patients who received Avastin plus radiation and chemotherapy lived significantly longer without their disease getting worse, and we plan to discuss these data with regulatory authorities.”The results of the Phase III AVAglio trial were presented in Plenary Session 5 by Professor Olivier Chinot, AVAglio principal investigator, President of Association des Neuro-Oncologue d'Expression Française (ANOEF), and head of the neuro-oncology department, University Hospital Timone, Marseille, France (Abstract OT-03, Saturday, November 17, 10:45 a.m. Eastern Time). AVAglio Study Results Primary endpoints:
- The 36 percent reduction in the risk of disease worsening or death can also be referred to as a 56 percent improvement in PFS (HR=0.64; p<0.0001).
- A 4.4 month improvement in median PFS was observed when people with newly diagnosed glioblastoma received Avastin in combination with radiation and chemotherapy compared to those who received radiation and chemotherapy plus placebo (10.6 months vs. 6.2 months, respectively).
- Interim results for OS did not reach statistical significance (HR=0.89; p=0.2135). Final data on OS are expected in 2013.
- An independent review committee assessment of PFS showed a 39 percent reduction in the risk of disease worsening or death, which can also be referred to as a 64 percent improvement in PFS (HR=0.61; p<0.0001). This was consistent with the magnitude of benefit assessed by the trial investigators.
- The one-year survival rate was 66 percent for the placebo arm versus 72 percent in the Avastin arm (p=0.052).
- Adverse events (Grade 3-5) of special interest occurred in 28.7 percent of patients in the Avastin arm compared to 15.2 percent of patients in the radiation and chemotherapy plus placebo arm. Adverse events (Grade 3-5) of special interest that occurred more often (>2 percent increased incidence) in the Avastin arm compared to the control arm were high blood pressure (10.3 percent vs. 2.0 percent) and too much protein in the urine (proteinuria; 3.7 percent vs. 0 percent).
- Avastin plus radiation and temozolomide chemotherapy for six weeks followed by a four-week break. Patients then received Avastin and temozolomide for up to six cycles, followed by Avastin alone until disease progression.
- Radiation, temozolomide and placebo for six weeks followed by a four-week break. Patients then received temozolomide and placebo for up to six cycles, followed by placebo until disease progression.