Prophage vitespen: Updated Phase II data

Updated data from a single-arm, U.S. Phase II trial in 46 patients with newly diagnosed GMB showed that intradermal Prophage G-100 plus standard of care (SOC) radiation and temozolomide led to a median PFS of 17.8 months with a 12-month PFS rate of 63% and a 24-month PFS rate of 20%. Additionally, Prophage G-100 plus SOC led to a 12-month OS rate of 85%. Agenus previously reported preliminary data from the trial showing that Prophage G-100 plus SOC led to a median PFS of 17 months and a median OS of 23.3 months. Agenus said historical controls treated with SOC alone had a median PFS of 6.9 months and a median OS of 14.6 months (see BioCentury, Aug. 5). The company said it plans to hold an end-of-Phase II meeting with FDA to discuss a Phase III trial with Prophage G-100 to treat newly diagnosed GBM, but declined to disclose a time frame for when the trial will start. ...