On July 15, 2015 Argos Therapeutics reported the pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of metastatic renal cell carcinoma (mRCC) has reached its enrollment goal of at least 450 randomized patients (Press release, Argos Therapeutics, JUL 15, 2015, View Source [SID:1234506335]).
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"Strong partnerships and coordination across our global study base to identify eligible patients and collect tumor samples have led to successful enrollment for the largest clinical trial ever conducted in patients with newly diagnosed, unfavorable risk, synchronous metastatic RCC," said ADAPT trial co-principal investigator and lead medical oncologist Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology and professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute. "With enough patients screened with successful tumor collection to meet and exceed our target of 450 randomized patients, we look forward to shifting our full attention to the treatment phase of the study and expected data readouts in 2016."
AGS-003 is an autologous dendritic-cell based immunotherapy designed to induce a memory T-cell response specific to each patient’s unique tumor antigens. It is produced using a small sample from a patient’s own tumor and dendritic cells derived from a leukapheresis procedure. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable risk mRCC patients.
To qualify for the ADAPT trial, patients were required to be good candidates for standard surgery and targeted drug therapy. During the enrollment process approximately 55 percent of patients who consented for tumor collection and screening for the treatment phase of the trial were found to be ineligible for treatment because of non-clear cell histology, lack of suitability to initiate standard targeted drug therapy, poor performance status, poor prognosis after surgery, a lack of evaluable metastatic disease, or other factors.
"By concluding enrollment in the ADAPT trial, we have reached an exciting milestone by demonstrating the ability to rapidly screen and collect tumor samples for more than 1,000 newly diagnosed metastatic RCC patients over the course of approximately two years," said ADAPT trial co-principal investigator and lead urologic oncologist Dr. Christopher Wood, professor of urology and deputy chairman of the department of urology, division of surgery at the University of Texas MD Anderson Cancer Center. "This would not have been possible without a strong multidisciplinary collaboration among urologists and oncologists, which positions us well to advance our evaluation of AGS-003 in addition to standard treatment through trial completion."
"The ADAPT trial is focused on a population with significant unmet needs as the expected median survival based upon International mRCC Database Consortium (IMDC) benchmarks is approximately 15 months after diagnosis, even with standard surgery and approved targeted therapies," said Doug Plessinger, vice president of clinical and medical affairs for Argos Therapeutics. "We continue to believe that the combination of standard treatment with our personalized immunotherapy has the potential to bring new hope to mRCC patients, and we look forward to the next interim data review from the ADAPT trial in the first part of 2016."
About the Arcelis Technology Platform
Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.