"The ADAPT phase 3 trial to evaluate AGS-003 in front line mRCC, the largest global trial ever performed in newly diagnosed, unfavorable risk mRCC patients, continues to progress nicely," said Dr. Figlin, the Steven Spielberg Family chair in hematology oncology, professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and the principal investigator for the ADAPT trial.
"We anticipate that we are approaching the mid-point for the expected number of events and look forward to the next interim review of the trial data in approximately six months."
AGS-003 is a fully individualized immunotherapy that captures mutated and variant antigens that are specific to each patient’s tumor and is designed to induce an immune response targeting that patient’s tumor antigens. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable (intermediate and poor) risk mRCC patients.
The randomized phase 3 ADAPT trial evaluating AGS-003 plus standard targeted therapy enrolled a total of 462 mRCC patients and has a primary endpoint of overall survival. AGS-003 is Argos’ most advanced Arcelis-based product candidate.
Argos president and CEO Jeffrey Abbey said: "We are excited by the IDMC’s recommendation to continue with the trial.
"This is an important step for the ADAPT trial and for the clinical development of AGS-003."