APG101: Final Phase II data

Final data from an open-label, international Phase II trial in 84 patients with GBM showed that once-weekly IV APG101 plus radiotherapy as second-line treatment led to a 6-month PFS rate, the primary endpoint, of 20.7% vs. 3.8% for radiotherapy alone (p=0.0485). Apogenix said the endpoint was considered met if the percentage of patients who were progression free at 6 months was increased by >100%. Median PFS was 19.7 weeks for APG101 plus radiotherapy vs. 10.8 weeks for radiotherapy alone (p=0.0114). Additionally, quality of life as measured by a standardized questionnaire improved in 67% of patients receiving APG101 plus radiotherapy, but worsened in 66% of patients receiving radiotherapy alone. Furthermore, >50% of patients who received APG101 plus radiotherapy were able to reduce or stop medication with corticosteroids vs. 28% of patients who received radiotherapy alone. The trial enrolled patients with GBM who had suffered first or second relapses and who no longer responded to temozolomide. ...