Treatment with AGS-003 in combination with sunitinib (Sutent) appears to be safe, well-tolerated, and associated with extended survival in patients with metastatic renal cell carcinoma (mRCC), according to new data from a phase II trial published in the Journal for ImmunoTherapy of Cancer.
Treatment with AGS-003 in combination with sunitinib (Sutent) appears to be safe, well-tolerated, and associated with extended survival in patients with metastatic renal cell carcinoma (mRCC), according to new data from a phase II trial published in the Journal for ImmunoTherapy of Cancer.1
AGS-003 is an autologous immunotherapy that is prepared using a patient's own dendritic cells and amplified tumor RNA. In a multicenter phase II trial, researchers found an encouraging median overall survival of 30.2 months for all patients treated with the combination of AGS-003 plus sunitinib. Similar unfavorable risk mRCC patients have an expected overall survival of 14.7 months, according to the International Metastatic Renal Cell Carcinoma Database Consortium. In this current phase II trial, patients with intermediate-risk mRCC experienced a median survival in excess of 5 years.
Data presented during the 2014 ASCO Genitourinary Cancers Symposium by Avishay Sella, MD, who is head of the Department of Oncology at Asaf Harofeh Medical Center in Israel, indicated the expected median survival for intermediate-risk mRCC patients treated with sunitinib as their first-line targeted therapy is approximately 20.5 months.
Phase II study investigator Asim Amin, MD, who is medical oncologist at the Levine Cancer Institute, Charlotte, North Carolina, said the outcomes in this study provide oncologists and their patients with new hope. He said mature data from this phase II study suggest the combination of AGS-003 plus sunitinib was safe, well-tolerated, and associated with doubling the expected median survival, and encouraging long-term and 5-year survival.
Study co-author Dr. Robert Figlin, MD, who is the chair of hematology-oncology and professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, Los Angeles, said observations from this study indicate that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival.
These findings are now being further evaluated in the ongoing phase III ADAPT study. This pivotal study is expected to complete enrollment of 450 mRCC patients in mid-2015, according to Argos Therapeutics, Inc.2 The company says there are also plans to advance studies of AGS-003 in earlier stages of renal cell carcinoma and other solid tumors later this year.
AGS-003 uses the Arcelis® Technology Platform, which is a fully personalized immunotherapy technology designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The phase III clinical trial compares the standard treatment for mRCC to the standard treatment plus the personalized vaccine. Every patient in the phase III trial will receive surgery, along with radiation therapy and chemotherapy to remove any remaining tumor cells. However, about two-thirds of the patients in the trial will receive the vaccine product as well.