Interim results from the ongoing Phase 3 ADAPT clinical trial for the investigational therapy Rocapuldencel-T (AGS-003) in patients with metastatic renal cell carcinoma, will be presented at the 2017 Congress of the European Society for Medical Oncology (ESMO) Sept. 8-12 in Madrid, Spain, Argos Therapeutics, the drug’s developer, announced.
Robert Figlin, MD, professor and chairman, Division of Hematology and Oncology at Cedars Sinai Medical Center, and co-lead investigator of the trial, will deliver the presentation: “Interim Analysis of the Phase 3 ADAPT Trial Evaluating Rocapuldencel-T (AGS-003), an Individualized Immunotherapy for the Treatment of Newly-Diagnosed Patients with Metastatic Renal Cell Carcinoma (mRCC).”
The presentation will provide an overview of the study data until the time of the interim analysis, which was conducted by an independent data monitoring committee (IDMC) earlier this year.
The ADAPT study (NCT01582672) will evaluate whether Rocapuldencel-T prolongs overall survival (OS) of patients with metastatic renal cell carcinoma when added to standard treatment. The outcomes of participants receiving Rocapuldencel-T will be compared to those treated with standard treatment alone, after 42 months or until 290 deaths have occurred.
Additional outcomes include patients’ progression-free survival and tumor response to therapy, including objective response rate, duration of overall response, and disease control rate.
Previous results from a Phase 2 study showed that newly diagnosed, unfavorable-risk metastatic renal cell carcinoma patients treated with a combination of Rocapuldencel-T with Sutent (sunitinib), the standard of care for the treatment of renal cell carcinoma, resulted in survival benefit of 30 months over controls.
Rocapuldencel-T is Argos’ most advanced investigational patient-tailored immunotherapy. This is because researchers use information retrieved from each patient’s tumor and their own class of dendritic cells, which are key cells in the immune system. This ensures patients’ dendritic cells are reprogrammed and activated to respond specifically to their own tumor cells, enhancing the therapy’s specificity and effectiveness. The patient’s reprogrammed dendritic cells are then administered via intradermal injection and works as a personalized immunotherapy.
Argos Therapeutics, based in North Carolina, is an immuno-oncology company developing and commercializing fully personalized immunotherapies for the treatment of cancer. The ADAPT trial is ongoing and final data collection target date for primary outcome measure is due December 2017.