ICT-107 is a dendritic cell (DC) vaccine for the treatment of newly diagnosed glioblastoma multiforme (GBM), the most common and lethal type of brain cancer. ICT-107 is designed to activate a patient’s immune system to target six different tumor-associated antigens.
ICT-107 has completed phase 2 testing with results reported in December 2013. Additional updated results were reported in June 2014 and November 2014. In November 2015, overall survival (OS) was additionally updated and reported. The phase 2 clinical trial was designed as a double-blind, placebo-controlled (2:1 randomized), multicenter evaluation of the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. From January 2011 until September 2012, the trial enrolled 278 patients at 25 centers throughout the U.S. and 124 patients were randomized to standard of care treatment plus ICT-107 or standard of care plus placebo (i.e., control).
The phase 3 registrational trial of ICT-107 in patients with newly diagnosed glioblastoma is designed as a randomized, double-blind, placebo-controlled study of a target number of about 500 HLA-A2+ subjects, which will be conducted at about 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival (OS). Secondary endpoints include progression-free survival (PFS) and safety, as well as overall survival in the two pre-specified MGMT subgroups.
The first patient in the phase 3 registrational trial was treated in June 2016. ImmunoCellular anticipates randomization of all patients by the first half of 2019, and an additional 2-3 years from then to achieve the number of required events to complete the trial. The Company plans to conduct a futility interim analysis upon reaching 30% of events, which should be at about the time of full randomization, and an efficacy interim analysis upon reaching 67% of events, which should be about six months later.
ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. ImmunoCellular has also been awarded $19.9 million from the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, for the phase 3 registration trial.
ICT-107 has been granted orphan drug designation in the US and Europe.
For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov/ct2/show/NCT02546102?term=ICT-107&rank=2