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AGS-003 improved OS in unfavorable-risk metastatic renal cell carcinoma

Issue: March 10, 2012

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2012 ASCO Genitourinary Cancers Symposium

Adding AGS-003 to sunitinib extended survival for patients with metastatic renal cell carcinoma compared with sunitinib monotherapy, according to results of a phase 2 study.

Previous study results showed that AGS-003, a personalized dendritic-cell immunotherapy, extended PFS for this patient population compared with historical controls.

Robert A. Figlin, MD, director of hematology/oncology at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, unveiled new evidence showing that AGS-003 also could improve OS when combined with sunitinib (Sutent, CPPI CV).

“Encouraging clinical and immunological responses have been observed and correlated with prolonged OS,” Figlin said. “The median PFS of 11.2 months and OS of 29.3 months for this group of patients that is often considered non-favorable, compares favorably to expectations with current kidney cancer therapies.”

Twenty-one patients were assigned one cycle of sunitinib followed by five doses of AGS-003, then a booster of AGS-003 until progression. They were evaluated for PFS and OS. Immune responses were assessed at baseline and after five AGS-003 doses using multiparametric flow cytometry.

Median PFS was 11.9 months for patients who received at least one dose of AGS-003. Median PFS was 14.9 months for intermediate-risk patients and 6 months for poor-risk patients.

Median OS was 29.3 months, which Figlin said compared favorably to historical outcomes. More than 40% of patients had survival longer than 30 months compared with 13% observed in earlier studies. Median OS for poor-risk patients was 7.9 months.

There were no grade-3/grade-4 immunotherapy-related adverse events reported. There has been no evidence of emergent autoimmune disease, Figlin said.

Partial response rate was 38% and clinical benefit rate was 62%. Additionally, 73% of patients saw increases in their CD28+CD45RA T cells after five doses of AGS-003.

For more information:

• Figlin RA. Abstract #348. Presented at: ASCO Genitourinary Cancers Symposium; Feb. 2-4, 2012; San Francisco.

Disclosure: Dr. Figlin reports serving as an unpaid consultant with Argos Therapeutics, AVEO, Bristol-Myers Squibb and Prometheus. He also reports receiving research funding from Argos.

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