Argos Therapeutics Inc (NASDAQ:ARGS) reported that the Independent Data Monitoring Committee for the firm’s pivotal Phase III ADAPT clinical study of rocapuldencel-T together with sunitinib/standard-of-care for the cure of mRCC has suggested that the trial be discontinued for futility depending on its planned interim data assessment. The IDMC stated that the trial was unlikely to show a statistically considerable improvement in OS in the combination therapy arm, using the intent-to-cure population, the main endpoint of the trial. The IDMC reported that rocapuldencel-T was usually well-tolerated in the study.
The details
In conjunction with its scientific and clinical advisors, Argos is assessing the preliminary ADAPT study data set and intends to discuss the report with the U.S. FDA. The firm intends to leave the ADAPT study open while the firm performs its ongoing data assessment and discussions with the U.S. FDA. Based on these discussions and analyses, the firm will make a purpose as to the next initiatives for the rocapuldencel-T clinical plan.
Jeff Abbey, the President and CEO of Argos Therapeutics, reported that they are extremely disappointed with the data, which included 75% of the targeted events required to allow the primary analysis and evaluation of overall survival in the trial. They sincerely appreciate the investigators and patients who have partook in the ADAPT Phase III study, and remain assured of the ability of precision immunotherapy to enhance the lives of patients.
Rocapuldencel-T is a customized immunotherapy that is intended to capture variant and mutated antigens that are definite to each patient’s tumor and encourage an immune response aiming that subject’s tumor antigens. The randomized Phase III ADAPT study assessing rocapuldencel-T plus sunitinib and standard-of-care treatment against standard-of-care treatment alone in newly diagnosed mRCC subjects was started in January 2013 and closed enrollment in 2015. As many as 462 mRCC subjects were randomized to the study. The primary endpoint of the study is a statistically notable improvement in OS.