IDMC recommends continuation of Argos’ ADAPT phase 3 trial of AGS-003 in mRCC patients

Jun 5 2015

Argos Therapeutics to host conference call with principal investigator Dr. Robert Figlin on Monday June 8, 2015 at 4:30pm EDT

Argos Therapeutics Inc. (Nasdaq: ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis^® technology platform, today announced 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.

The IDMC recommendation coincided with an update on enrollment in the ADAPT trial presented at the 2015 American Society of Clinical Oncology (ASCO) 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.

“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, the IDMC recommendation to continue the trial, and to answer questions.

Source: http://www.argostherapeutics.com/