Date: 2016-03-16
Type of information: DSMB assessment
phase: 3
Announcement: DSMB assessment
Company: Argos Therapeutics (USA - NC)
Product: AGS-003
Action
mechanism: cell therapy/immunotherapy product. AGS-003 is an autologous dendritic-cell based immunotherapy designed to induce a memory T-cell response specific to a patient's 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 (intermediate and poor) risk mRCC patients.
Disease: metastatic renal cell carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: 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.
Latest
news: * On June 13, 2016, Argos Therapeutics announced that the independent data monitoring committee (IDMC) for the Company's pivotal Phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) has recommended the continuation of the trial based on results of the IDMC's scheduled interim data review. The next IDMC meeting is being planned to coincide with the Genitourinary Cancers Symposium in February 2017. The positive outcome from the IDMC's review of the ADAPT trial data triggers the second tranche of the financing under the Company's previously announced March 2016 securities purchase agreement. Upon the closing of the second tranche, which is expected to occur within 30 days, the Company will receive a total of $29,824,520 from the sale of a total of 5,478,672 shares of common stock and warrants to purchase a total of 4,109,005 shares of common stock. * On December 10, 2015, Argos Therapeutics announced its 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) based on results of the committee's second planned interim data analysis. The randomized phase 3 ADAPT trial evaluating AGS-003 plus standard targeted therapy enrolled a total of 462 mRCC patients and has a primary endpoint of overall survival. AGS-003 is Argos' most advanced Arcelis-based product candidate. * On July 15, 2015, Argos Therapeutics, 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, announced 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. "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." * On June 4, 2015, Argos Therapeutics 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 thestudy thus far. * On May 13, 2015, Argos Therapeutics 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).
