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.
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.