MedicalResearch.com: What are the main findings of the study?
Dr. Weber: That the PD-1 blocking antibody nivolumab has a 25% ORR with long duration of response in ipilimumab refractory patients, and that patients with prior grade 3-4 ipilimumab related immune related side effects may be safely treated with nivolumab without reproducing the prior IPI related side effects.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Weber: The correlative studies done as part of this clinical trial showed that high levels of pre-existing antigen specific tumor specific CD8 T cells were associated with a poor outcome with nivolumab.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Weber: That nivolumab is a very active drug in unresectable melanoma in patients that have failed other therapies and are ipilimumab naïve or –refractory.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Weber: Sequential and concurrent nivolumab and ipilimumab are worth studying, and that important findings will be obtained by studying the phenotype and function of existing circulating and tumor infiltrating immune T cells prior to treatment with PD-1 antibody to develop possible predictive markers for the drug.
Jeffrey S. Weber, Ragini Reiney Kudchadkar, Bin Yu, Donna Gallenstein, Christine E. Horak, H. David Inzunza, Xiuhua Zhao, Alberto J. Martinez, Wenshi Wang, Geoffrey Gibney, Jodi Kroeger, Cabell Eysmans, Amod A. Sarnaik, and Y. Ann Chen