Positive data from Argos Therapeutics' AGS-003 Phase 2 trial for mRCC

Argos Therapeutics today announced the presentation of positive data from a Phase 2 trial that evaluated the safety, clinical response and immune response of AGS-003 treatment in newly diagnosed patients with metastatic renal cell carcinoma (mRCC). The data were discussed March 7 in a poster presentation at the ASCO Genitourinary Cancers Symposium. AGS-003 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique tumor burden. According to results from the study, AGS-003 induced a tumor-specific immune response, performed better than interferon-α on a measure of progression-free survival, and was well tolerated.

“A Phase 1/2 Study of AGS-003, a Personalized Immunotherapeutic Evaluated in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) Subjects”

“These results serve as preliminary proof-of-concept for AGS-003, demonstrating that this immunotherapy is able to induce an immune response to the very patient-specific tumor antigens that are targeted,” said Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics. “This study not only demonstrates a favorable safety profile and early signs of efficacy, but the results also compare favorably to historical results with standard immunotherapy approaches in mRCC patients. These results provide a strong basis for the ongoing Phase 2 trial evaluating the therapy in combination with sunitinib.”

“Patients enrolled in this trial were a higher-risk, poorer-prognosis population with reduced expectations for clinical response and survival,” said Theodore Logan, M.D., of the Indiana University Simon Cancer Center and lead author on the poster. “Thus, the clinical benefit, excellent safety profile and immunologic responses observed in this study were quite encouraging. These results compare favorably to historical results with interferon-α in an unfavorable risk group of patients and represent an encouraging development in the continued search for novel, well tolerated immunotherapy approaches in this patient population.”

At the study’s baseline, the majority of evaluable patients, all of which were classified as either MSKCC intermediate or poor-risk, suffered impaired cellular immunity to RCC tumor antigens; however, following AGS-003 treatment, the majority of evaluable patients experienced detectable cellular immunity to these same antigens, demonstrating that AGS-003 induced a tumor-specific immune response. Additionally, 50% of patients had restored T cell-mediated interleukin-2 and interferon-γ responses, indicating general immune reconstitution. The median length of progression-free survival (PFS), from time of registration, was 5.6 months, in contrast to the historical median PFS for interferon-α of 5.1 and 2.5 months for intermediate and poor-risk subjects, respectively. Forty percent of subjects experienced a clinical benefit, defined as either a partial response or stable disease. AGS-003 was well tolerated, with no drug-related serious adverse events or grade 3/4 adverse events observed.

This open-label Phase 2 trial enrolled 20 evaluable, newly diagnosed post-nephrectomy patients with clear cell mRCC. Subjects received intradermal injections of AGS-003 in the following sequence: 5 biweekly doses, 4 monthly doses, and 1 dose every 3 months until disease progression. Primary endpoints of the study included clinical and immune response, and secondary endpoints included safety, PFS and overall survival.