Argos Therapeutics to Continue Adapt Trial Despite IDMC Recommendation to Discontinue Study
April 19, 2017 at 02:22 am IST
Share
Argos Therapeutics announced that it will continue its Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma despite the recommendation of the Independent Data Monitoring Committee that the study be discontinued for futility. The IDMC had conducted the most recent interim analysis of the study's results in February 2017. At the time of the interim analysis, the estimated median overall survival for the combination arm was 27.7 months compared to 32.4 months for the control arm. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC noted that Rocapuldencel-T was generally well-tolerated in the trial. The company determined to continue to conduct the trial pending further review and analysis of the data and discussions with the FDA. In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of long-term memory immune responses, and the IDMC's assessment of the safety profile of Rocapuldencel-T. Of note, at the time of the IDMC's February interim analysis, the median duration of follow-up was 20.0 months and more than half the patients in both treatment groups were still alive. The company continues to analyze the data from the trial and plans to meet with the FDA in May 2017, but currently believes based on the data it has reviewed that the trial should be continued until completion. Based on these analyses and discussions, the company will make a determination as to the next steps for the Rocapuldencel-T clinical program.
Argos Therapeutics, Inc. (Argos) is an immuno-oncology company. The Company is focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases based on its technology platform called Arcelis. The Company's Arcelis technology platform utilizes biological components from a patient's own cancer cells or virus to generate individualized immunotherapies. The Company is engaged in the development of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC), and other cancers. It is conducting a pivotal Phase III clinical trial of AGS-003 plus sunitinib or another targeted therapy for the treatment of newly diagnosed mRCC under a special protocol assessment (SPA). It is engaged in the development of AGS-004 for the treatment of Human Immunodeficiency Virus (HIV). It has conducted over three clinical trials of AGS-004, including a Phase IIb clinical trial, Phase IIa clinical trial and Phase I clinical trial.