An investigational autologous immunotherapy used in combination with sunitinib significantly improved long-term survival in patients with unfavorable-risk metastatic renal cell carcinoma (mRCC), researchers reported at the American Society of Clinical Oncology annual meeting in Chicago.
In a phase 2 study of 21 subjects who received the dual regimen, investigators Asim Amin, MD, PhD, of the Levine Cancer Institute in Charlotte, N.C., and colleagues observed a doubling of the expected median progression-free survival (PFS) and overall survival (OS), with 52% of patients surviving more than 30 months and 23% surviving for more than 5 years. The patients received 5 doses of the immunotherapy spaced 3 weeks apart.
For all patients, the time from diagnosis to the initiation of treatment was less than 1 year. The expected median PFS and OS in these patients, based on an analysis by the International mRCC Database Consortium, are 5.6 and 14.7 months, respectively, the researchers pointed out.
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The autologous immunotherapy, AGS-003, provides 3 signals required to generate an adaptive immune response, the researchers explained in a poster presentation. These signals stimulate production of effector memory cytotoxic T lymphocytes.
The memory T-cell response observed after 5 doses of AGS-003 correlates with prolonged survival, Dr. Amin’s group reported.
The immunotherapy, which being developed by Argos Therapeutics, of Durham, N.C., is now being studied in a phase 3 trial.
