On June 4, 2015 Argos Therapeutics reported an independent data monitoring committee (IDMC) has recommended the continuation of the company’s pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) following the first of three planned interim data analyses (Press release, Argos Therapeutics, JUN 4, 2015, View Source [SID:1234505229]). Schedule your 30 min Free 1stOncology Demo! The IDMC recommendation coincided with an update on enrollment in the ADAPT trial presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by principal investigator 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. In a poster presentation titled "Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience" (abstract TPS4582), Dr. Figlin noted more than 1,000 tumor samples have been collected and approximately 400 patients have been randomized to the treatment phase of the study thus far.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are very pleased with the progress of the ADAPT phase 3 trial to evaluate AGS-003, which is generating great interest within the advanced kidney cancer community," said Dr. Figlin. "We look forward to further IDMC reviews and interim data readouts as we advance the largest global trial ever performed in the newly diagnosed, unfavorable risk mRCC patient population."
AGS-003 is an autologous dendritic-cell based immunotherapy designed to induce a memory T-cell response specific to a patient’s tumor antigens. 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. The randomized phase 3 ADAPT study evaluating standard targeted therapy plus AGS-003 is designed to enroll about 450 mRCC patients in total.
"We are on the cusp of a very important and exciting period in the development of AGS-003," said Mr. Jeffrey D. Abbey, president and chief executive officer of Argos. "We welcome the IDMC recommendation to continue our pivotal ADAPT trial and are in position to complete patient enrollment this summer as planned."
Conference Call and Webcast Details
Argos executive management will host a conference call with Dr. Figlin beginning at 4:30pm EDT on Monday June 8, 2015 to discuss the ADAPT trial update presented at ASCO (Free ASCO Whitepaper), the IDMC recommendation to continue the trial, and to answer questions.
To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 61247434. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for 14 days following the call.
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.