Argos Therapeutics Inc., a company focused on personalized immunotherapies for cancer treatment, recently announced that the ongoing pivotal phase 3 ADAPT clinical trial (NCT01582672) of its product AGS-003 for the treatment of metastatic renal cell carcinoma has enrolled approximately 400 patients and collected more than 1,000 cancer samples.
Argos’ AGS-003 is a product based on the company’s Arcelis Technology Platform, which is a fully personalized immunotherapy technology designed to overcome immunosuppression by inducing a durable memory T cell response specific for each patient’s cancer. AGS-003 is produced using a small sample from the patient’s tumor and own dendritic cells (scavengers that recognize cancer cells and present them to T cells in order to mount an immune response). These are collected and optimized following a single leukapheresis procedure, a process in which white blood cells are separated from a blood sample. RNA is isolated from the patient’s tumor sample in order to program dendritic cells to target specific cancer antigens. These activated dendritic cells are then administered back into the patient.
“We have observed a significant level of interest in this trial evaluating AGS-003, a fully customized and well-tolerated immunotherapy, in combination with standard surgery and targeted therapy for patients who present with newly diagnosed, metastatic kidney cancer,” said ADAPT trial principal investigator Dr. Robert Figlin in the press release. “With the strong multidisciplinary collaboration between urologists and oncologists across our study base, we are excited to be completing enrollment to this important trial in the coming weeks.”
The ADAPT trial is expected to enroll around 450 patients who are good candidates for standard surgery and targeted drug therapy. Argos plans to conclude the ADAPT trial enrollment phase by the end of June 2015.
Dr. Figlin will present data on the ADAPT trial at the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, on June 1st in a poster entitled “Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience”.
“We continue to be pleased and highly encouraged by the tremendous interest in the largest global trial ever performed in the newly diagnosed, unfavorable risk mRCC [renal cell carcinoma] patient population,” said the President and CEO of Argos, Jeff Abbey. “Even with surgery and approved targeted therapies, these mRCC patients are only expected to survive an average of 15 months after diagnosis. We look forward to the readout from this trial by the second half of 2016, when we hope to confirm the encouraging survival results we observed in our phase 2 trial involving AGS-003 combined with sunitinib [an anti-cancer drug].”
Metastatic renal cell carcinoma patients have an extremely poor five-year survival rate and, different from other types of cancer, patients usually have a poor response to chemotherapy and radiation therapy. New effective therapies are therefore urgently needed.
If you are interested in participating in this Phase 3 clinical trial, please contact the Adapt Study Team via [email protected] or 1-877-573-9235.