Rindopepimut: Final Phase IIb data

Final data from the single-arm, open-label Phase IIb ACT III trial in 65 patients showed that rindopepimut plus granulocyte-macrophage colony-stimulating factor (GM-CSF) met the primary endpoint of significantly improving the rate of PFS at 5.5 months post-treatment (8.5 months post-diagnosis) vs. a predetermined estimate that the company said is beyond the range of expected PFS for standard of care (SOC) alone (66% vs. 53%, p=0.0168). Rindopepimut led to median PFS and estimated OS from diagnosis of 12.3 and 24.3 months, respectively, with a 50% OS rate at 24 months. Data were presented at the Society for Neuro-Oncology meeting in Montreal. ...