The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug.
The drug being trialled was a monoclonal antibody called ipilimumab, then under development at BMS with Axel Hoos as the medical lead.
The Phase III clinical failure of Pfizer's tremelimumab anti-CTLA-4 monoclonal antibody, which competed with ipilimumab, provided the first large-scale evidence of the utility of the irRC.
The Pfizer study used conventional response criteria, and an early interim analysis found no survival advantage for the treated patients, leading to the termination of the trial in April 2008.
[7] [8] However within a year of this development, Pfizer's investigators were beginning to notice a separation of survival curves between treatment and control groups.
The 2009 paper which described the new irRC had twelve authors, all associated with the ipilimumab clinical trials used as examples - Jedd Wolchok of Memorial Sloan Kettering Cancer Center, Axel Hoos and Rachel Humphrey of Bristol-Myers Squibb, Steven O'Day and Omid Hamid of the Angeles Clinic in Santa Monica, Ca., Jeffrey Weber of the University of South Florida, Celeste Lebbé of Hôpital Saint-Louis in Paris, Michele Maio of University Hospital of Siena, Michael Binder of Medical University of Vienna, Oliver Bohnsack of a Berlin-based clinical informatics firm called Perceptive Informatics, Geoffrey Nichol of the antibody engineering company Medarex (which had originally developed ipilimumab) and Stephen Hodi of the Dana–Farber Cancer Institute in Boston.