Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® technology platform, today 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.
"Our report discusses truly remarkable cases from a Phase 2 study, where two intermediate risk mRCC patients have sustained an immune response to their disease for many years," said lead author Gautam Jha, MD, medical oncologist at the University of Minnesota. "Perhaps most importantly, we have observed an increase in the number of effector memory T-cells associated with improved Overall Survival (OS) in 14 patients who received at least 5 doses of AGS-003. Considering AGS-003 is well-tolerated without significant additional side effects over single agent sunitinib, this investigational therapy remains promising for patients with advanced kidney cancer."
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 designed AGS-003 to capture the mutated and variant antigens that are unique to each patient's tumor to induce a robust targeted immune response. This individualized immunotherapy is created using a small tumor sample and the patient's own dendritic cells collected in a leukapheresis procedure. RNA is isolated from the tumor sample and used to program dendritic cells to target disease-specific antigens. Activated, antigen-loaded dendritic cells are then formulated with the patient's plasma, and administered via intradermal injection as an individualized immunotherapy.
"By capturing the array of known, unknown, and mutated antigens present in an individual patient's specific cancer, AGS-003 appears to elicit a broad, individualized anti-tumor immune response," said Lee F. Allen, MD, PhD, chief medical officer of Argos. "We remain focused on aggressively advancing our development program through late-stage clinical research, and continue to be encouraged by the long-term outcomes from the Phase 2 study."
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).