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Hearn Jay Cho, MD, PhD, associate professor of medicine, Hematology/Oncology, Icahn School of Medicine, Mount Sinai Hospital, discusses ongoing research with checkpoint inhibitors in multiple myeloma.
Hearn Jay Cho, MD, PhD, associate professor of medicine, Hematology/Oncology, Icahn School of Medicine, Mount Sinai Hospital, discusses ongoing research with checkpoint inhibitors in multiple myeloma.
In the interim analyses of studies evaluating pembrolizumab (Keytruda) combinations, it was noted that there were higher numbers of deaths in the experimental arms than in the control arms, states Cho. Those in the experimental arms were either treated with a combination of pembrolizumab and pomalidomide (Pomalyst) or lenalidomide (Revlimid) and dexamethasone, while those in the control arm received either pomalidomide and dexamethasone or lenalidomide and dexamethasone. Some expressed concern that these deaths were due to immune-related adverse events. Moreover, there did not appear to be a survival difference between the experimental arm and the control arm.
These trials were only partially accrued at the time that these interim analyses were done, says Cho. Subsequent review of the data revealed that there were some potential imbalances in the patient arms because the trials had yet to fully accrue. Nonetheless, the FDA halted the trials for review, and subsequently, sponsors closed the trials. However, based on the phase I/II trials, there appears to be activity with these agents that warrant further investigation, says Cho.