Argos Therapeutics Inc. Reports Interim Results of the ADAPT Trial and Provides Perspective on Decision to Continue the Trial
April 19, 2017 at 01:35 am IST
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Argos Therapeutics Inc. reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC). The Company also provided perspective on its decision to continue the trial. A total of 462 patients were enrolled in the ADAPT study and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm). For both arms, the protocol permits switching to other standard-of-care treatments for mRCC for reasons such as intolerance to therapy or disease progression. The primary efficacy endpoint for the study is a statistically significant improvement in overall survival, with secondary efficacy endpoints evaluated to date of progression-free survival, objective response rate and disease control rate, and an exploratory efficacy endpoint of immune response. The trial was opened in January 2013 and completed enrollment in July 2015 at 107 sites across North America, Europe and Israel. The most recent interim analysis was conducted by the Independent Data Monitoring Committee (IDMC) in February 2017 (data cut-off as of February 3, 2017) after 75% of the targeted number of 290 events (deaths) for the analysis of the primary endpoint of overall survival had occurred. In accordance with the statistical analysis plan, median overall survival was estimated using the Kaplan-Meier method. At the time of the interim analysis, the estimated median overall survival for the combination arm was 27.7 months (95% Confidence Interval (CI): 23.0, 35.9) compared to 32.4 months (95% CI: 22.5, -) for the control arm. The hazard ratio was 1.10 (95% CI: 0.83, 1.46), which was greater than the pre-defined futility boundary for the final interim analysis of 0.98. As a result, the IDMC recommended that the study be discontinued for futility. 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 also noted that Rocapuldencel-T was generally well-tolerated in the trial.
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.