Date: 2016-11-03
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in the Kidney Cancer Journal
Company: Argos Therapeutics (USA - NC)
Product: AGS-003
Action
mechanism: cell immunotherapy. AGS-003 is an autologous immunotherapy that is prepared using a patient's own dendritic cells and amplified tumor RNA.
Disease: metastatic renal cell carcinoma (mRCC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 3, 2016, Argos Therapeutics announced the publication of a Case Report in the Kidney Cancer Journal which details the clinical outcomes of two patients with intermediate risk metastatic renal cell carcinoma who had participated in a Phase 2 clinical trial of the company's investigational immunotherapy AGS-003 in combination with sunitinib. These patients have obtained long-term control of metastatic disease that is ongoing seven years after initiation of treatment. In the open-label Phase 2 clinical trial, 21 patients with newly-diagnosed, intermediate and poor risk mRCC were treated with AGS-003 plus sunitinib as a first-line therapy. Results demonstrated a median Progression Free Survival (PFS) of 11.2 months and median OS of 30.2 months for all patients. Five patients in the trial survived for more than five years, and two patients have maintained durable immune responses for seven years. According to the International mRCC Database Consortium, similar unfavorable risk mRCC patients have an expected OS of only 14.7 months. In addition, follow-up analysis of these Phase 2 data, approximately two years after database lock, demonstrated a median OS of 61.9 months for the intermediate risk patients in the study compared with 20.7 months for similar patients in the International mRCC Database Consortium. Argos is currently evaluating AGS-003 in combination with standard-of-care targeted therapy in the pivotal ADAPT Phase 3 clinical trial for the treatment of mRCC. Enrollment in this 462-patient study was initiated in February 2013 and completed in July 2015. The Independent Data Monitoring Committee (IDMC) for this study most recently recommended continuation of the study following a meeting in June 2016, with the next IDMC meeting planned for February 2017. In addition, AGS-003 is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of non-small cell lung cancer (NSCLC). * On April 21, 2015, Argos Therapeutics, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, announced that data from a Phase 2 clinical trial of AGS-003, the company's lead product candidate for the treatment of metastatic renal cell carcinoma (mRCC), have been published in the Journal for ImmunoTherapy of Cancer. The study findings show that treatment with AGS-003 in combination with sunitinib was safe, well tolerated and associated with immunologic responses and extended survival. In the multicenter Phase 2 trial led by Dr. Asim Amin, medical oncologist at the Levine Cancer Institute, encouraging median overall survival of 30.2 months was observed for all patients treated with the combination of AGS-003 plus sunitinib. According to the International mRCC Database Consortium, similar unfavorable risk mRCC patients have an expected overall survival of 14.7 months. In addition, in the Phase 2 trial, patients with intermediate risk experienced a median survival in excess of 5 years. Data presented during the 2014 ASCO Genitourinary Cancers Symposium by Dr. Avishay Sella, head of the Department of Oncology at Asaf Harofeh Medical Center in Israel, indicate the expected median survival for intermediate risk mRCC patients treated with sunitinib as their first line targeted therapy is approximately 20.5 months. The Journal for ImmunoTherapy of Cancer paper is titled, "Survival with AGS-003, an autologous dendritic cell--based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results."
