Immunotherapy for kidney cancer - Phase 3 update from Argos Therapeutics at ASCO

May 14 2015

Argos Therapeutics Inc., 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 that more than 1,000 tumor samples have been collected and approximately 400 eligible patients have been randomized to the company’s ongoing, pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC).

“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, 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 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.”

Argos is developing AGS-003, which is a fully personalized immunotherapy designed to induce a durable memory T-cell response specific to each patient’s cancer. It is produced using a small sample from a patient’s own tumor and dendritic cells derived from a leukapheresis procedure. For most patients, multiple years of treatment can be produced using this tumor sample and just one leukapheresis procedure, based upon the advanced Arcelis® technology platform.

The ADAPT trial is designed to enroll approximately 450 patients. To qualify, patients must be good candidates for standard surgery and targeted drug therapy. Thus far more than 50 percent of patients who have consented for tumor collection and been screened for the treatment phase of the trial have been ineligible for treatment because of non-clear cell histology, ineligibility for targeted drug therapy, poor performance status, poor prognosis after surgery, a lack of evaluable metastatic disease, and other factors. The company expects to conclude the enrollment phase of the ADAPT trial by the end of June 2015.

Dr. Figlin will present ADAPT trial insights at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting at McCormick Place in Chicago during the Genitourinary (Nonprostate) Cancer poster session on Monday, June 1^st from 1:15-4:45pm CT. The poster is titled, “Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience” (abstract TPS4582).

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 patient population,” said Jeff Abbey, president and CEO of Argos. “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