This article is more than 5 years old. Information may no longer be current.
AGS-003 plus sunitinib extended survival in metastatic RCC
Click Here to Manage Email Alerts
The combination of personalized immunotherapy and sunitinib nearly doubled the expected survival among a cohort of patients with unfavorable-risk metastatic renal cell carcinoma, according to results of a phase 2 study presented at the Genitourinary Cancers Symposium.
VEGF-targeted therapies — the standard treatment for patients with advanced renal cell carcinoma (RCC) — have improved efficacy but often are not associated with durable remissions, especially among patients with unfavorable-risk disease.
Prior research showed treatment with sunitinib (Sutent, CPPI CV), a multitargeted receptor tyrosine kinase inhibitor, conferred a median OS of 5.3 months for poor-risk patients and 20.7 months for intermediate-risk patients, according to background information in the abstract.
In the current investigation, Asim Amin, MD, PhD, co-director of the immunotherapy program at Levine Cancer Institute in Charlotte, N.C., and colleagues evaluated the combination of sunitinib and autologous dendritic cell immunotherapy (AGS-003) in 21 patients with metastatic RCC. Eleven patients had intermediate-risk disease and 10 were classified as poor risk.
All patients underwent standard 6-week cycles of sunitinib plus AGS-003 (once every 3 weeks, for five doses, then every 12 weeks until disease progression).
PFS and OS served as the primary endpoints.
Among the entire cohort, median PFS was 11.2 months and median OS was 30.2 months.
When researchers stratified the results by baseline risk status, they reported a median PFS of 5.8 months for poor-risk patients and 19.4 months for intermediate-risk patients. OS was 9.1 months among poor-risk patients and 39.5 months among intermediate-risk patients.
Eight of the 21 patients were still alive at the time the findings were presented.
“The results from this single-arm, phase 2 study represent a near-doubling of expected PFS and OS for unfavorable-risk subjects treated with AGS-003 plus sunitinib,” Amin and colleagues wrote. “These results support the ongoing phase 3 ADAPT study, which is designed to validate these encouraging clinical and immunologic findings.”
For more information:
Amin A. Abstract #357. Presented at: Genitourinary Cancers Symposium; Feb. 14-16, 2013; Orlando, Fla.
Disclosure: The researchers report consultant/advisory roles with or stock ownership in Argos Therapeutics and Axcelo MSL solutions.
Perspective
Back to Top
Leonard Gomella, MD, FACS
Advanced metastatic kidney cancer carries a poor prognosis, with newer oral medications and immunotherapy each showing some modest improvements in survival. This study uses a patient's own specific cancer-fighting immune cells (AGS-003) in combination with a standard oral medication, sunitinib, known as a targeted therapy that blocks kidney cancer's specific pathways that contribute to cancer growth and survival. This novel combination therapy using patient-specific immunotherapy combined with an oral agent showed significant benefits, with a doubling of survival in patients with aggressive metastatic kidney cancer. This is very encouraging and will need to be confirmed in a larger number of patients.
Click Here to Manage Email Alerts