Argos Therapeutics Inc (NASDAQ:ARGS) posted interim results from its multi-center Phase III ADAPT study of Rocapuldencel-T to be administered with sunitinib for the treatment of metastatic renal cell carcinoma. The firm offered perspective on its decision to advance the study.
A total of 462 subjects were registered in the ADAPT trial and randomized 2:1 between Rocapuldencel-T and sunitinib combination treatment versus sunitinib monotherapy. For both types, the protocol allows switching to other standard treatments for mRCC for numerous reasons like intolerance to treatment or disease progression.
The key efficacy endpoint for the trial is a statistically significant progress in overall survival, with secondary efficacy objectives assessed to date of objective response rate, disease control rate and progression-free survival, and an exploratory efficacy objective of immune response. The study was started in 2013 and closed enrollment in 2015 at 107 sites across Europe, Israel and North America.
The recent interim assessment was performed by Independent Data Monitoring Committee in February 2017 after 75% of the aimed number of 290 events for the assessment of the primary objective of overall survival had happened. As per the statistical analysis program, median OS was projected utilizing the Kaplan-Meier process.
During interim analysis, the projected median OS for the combination arm stood at 27.7 months against to 32.4 months for the control arm. Argos reported that the hazard ratio stood at 1.10, which was higher than the pre-defined ineffectiveness limit for the final interim assessment of 0.98.
Hence, the IDMC suggested that the trial be discontinued for futility. It concluded that the trial was unlikely to show a statistically considerable improvement in OS in the combination arm, using the intent-to-treat people, the main endpoint of the trial.
The IDMC stated that Rocapuldencel-T was usually well-tolerated in the study. Argos continues to assess the data from the study and intends to meet with the U.S. FDA in May 2017.