Gil Roth12.12.13
ImmunoCellular Therapeutics (ICT) posted results from its randomized, placebo-controlled Phase II trial of dendritic cell-based vaccine ICT-107 in patients with newly diagnosed glioblastoma multiforme (GBM). The vaccine demonstrated a statistically significant increase in progression-free survival (PFS), but missed its primary endpoint of overall survival (OS), which was not statistically significant compared to placebo.
Median progression-free survival times were two months longer for ICT-107 compared to placebo. The differences in OS did not reach statistical significance in the intent-to-treat population (the primary endpoint) or the per-protocol population.
The OS analysis includes data on 67 events (patient deaths) out of a possible 124, whereas the PFS analysis includes data from 103 events. The company plans to continue following patients in this trial to collect more mature OS data. In the matured data from the open label, Phase I trial, ICT observed a consistent benefit in both PFS and OS compared with historical controls, and on this basis, the company contends that it is possible that the primary OS benefit could be clarified as the Phase II data mature.
In this Phase II study, ICT-107 was generally safe and well tolerated, with no imbalance of adverse events between the active and placebo groups. The company will discuss its next steps, including a Phase III trial, with the FDA in an end-of-phase-II meeting.
Median progression-free survival times were two months longer for ICT-107 compared to placebo. The differences in OS did not reach statistical significance in the intent-to-treat population (the primary endpoint) or the per-protocol population.
The OS analysis includes data on 67 events (patient deaths) out of a possible 124, whereas the PFS analysis includes data from 103 events. The company plans to continue following patients in this trial to collect more mature OS data. In the matured data from the open label, Phase I trial, ICT observed a consistent benefit in both PFS and OS compared with historical controls, and on this basis, the company contends that it is possible that the primary OS benefit could be clarified as the Phase II data mature.
In this Phase II study, ICT-107 was generally safe and well tolerated, with no imbalance of adverse events between the active and placebo groups. The company will discuss its next steps, including a Phase III trial, with the FDA in an end-of-phase-II meeting.