The combination of two immune checkpoint inhibitors (ICPIs) with the standard-of-care chemotherapy (a hypomethylating agent called Azacitidine) displayed significant performance in the treatment of relapsed or refractory acute myeloid leukemia (AML). Further details about the phase 2 clinical study will be presented in early December at the 60th American Society of Hematology Annual Meeting & Exposition in San Diego.
Two patient cohorts were set up, one receiving Azacitidine (AZA) plus Nivolumab, the other having Ipilimumab in addition to those drugs. Information released so far reports a complete response rate of 43% with a 112-month survival rate of 58% for the second group, compared to only 22% complete response and 40% one-year survival.
Naval Daver, M.D., associate professor of the Leukemia Department at the University of Texas MD Anderson Cancer Center is heading the research. He noted that “the response rate and survival in patients with relapsed AML treated with azacitidine with both nivolumab and ipilimumab, appears encouraging and potentially superior to azacitidine with nivolumab in a small cohort of patients”, but further investigation is required before drawing a definitive conclusion.
To this extent, a new set of trials is set to begin in the near future. “The current triple therapy cohort will enroll up to 30 patients, and after that, we plan to open a new cohort that will evaluate a higher dose of ipilimumab and a lower dose of nivolumab in 30 patients,” said Daver. “Once we analyze both cohorts and select the appropriate dosing approach, we hope to evaluate this approach in a larger multi-center study”.
An in-depth correlative analysis to identify biomarkers of response and resistance is scheduled to take place on pre- and on-treatment bone marrow and blood samples for all patients in MD Anderson’s Immunotherapy Platform.
If these findings can be replicated, this would mean incredible news for people suffering from one of the most relentless forms of cancer.