BioCentury
ARTICLE | Clinical News

AV0113: Preliminary Phase II data

April 15, 2013 7:00 AM UTC

Activartis reported preliminary data from the open-label, Austrian Phase II GBM-Vax trial in about 100 brain cancer patients aged 18-70 years showing that AV0113 administered into inguinal lymph nodes as an add-on to standard therapy with radiotherapy and Temodar temozolomide (switched to Avastin bevacizumab upon disease recurrence) missed the primary endpoint of improving mean PFS vs. standard therapy alone (243 vs. 226 days). The company said control of tumor growth through cancer immunotherapies is achieved by inflammation, thus resulting in greater edema and infiltration with immune cells. Activartis said this may result in pressure-induced neurological symptoms that are wrongly interpreted as disease progression.

However, the company said there was a trend suggesting a survival benefit in patients in the AV0113 arm compared to the control arm (453 vs. 361 days). In 68 evaluable patients, AV0113 plus standard therapy led to a 12-month OS rate of 64% vs. 48% for standard therapy alone. In 33 evaluable patients, AV0113 plus standard therapy led to an 18-month OS rate of 50% vs. 33% for standard therapy alone. Activartis said the OS data are immature as they are based on an analysis of about a third of the recruited patients. AV0113 was well tolerated with no treatment-related serious adverse events reported. Patients received standard therapy alone or 4 weekly doses of AV0113 after 6 weeks of standard therapy followed by 6 doses every 4 weeks during maintenance therapy and 1 booster dose every 3 months. Data were presented at the American Association for Cancer Research meeting in Washington, D.C. ...