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Paul G. Richardson, MD, discusses the overall survival benefit displayed by isatuximab plus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.
Paul G. Richardson, MD, clinical program leader, director of Clinical Research, Jerome Lipper Multiple Myeloma Center, physician, Dana-Farber Cancer Institute, RJ Corman professor of Medicine, Harvard Medical School, discusses the overall survival (OS) benefit displayed by isatuximab (Sarclisa) plus pomalidomide (Pomalyst) and dexamethasone in patients with relapsed or refractory multiple myeloma.
The phase 3 ICARIA-MM trial (NCT02990338) evaluated isatuximab in combination with pomalidomide and dexamethasone vs pomalidomide plus dexamethasone alone in patients withrelapsed/refractory multiple myeloma.
Based on survival events that occurred prior to the data cutoff, findings presented at the 19th Annual International Myeloma Society Meeting showed that isatuximab plus pomalidomide and dexamethasone produced a clinically meaningful OS benefit vs pomalidomide and dexamethasone alone, Richardson says. The triplet elicited a median OS of 25 months compared with 18 months for the doublet (HR, 0.776; one-sided P < .0319), Richardson explains.
However, the prespecified statistical significance level was P < .02, therefore the isatuximab, pomalidomide, and dexamethasone combination did not meet this preplanned point for statistical significance, Richardson notes.
Despite not meeting the threshold for statistical significance, this 7-month difference in median OS is still clinically meaningful, Richardson continues. Investigators hypothesized that subsequent treatment with daratumumab (Darzalex) affected the ability of the OS benefit to reach statistical significance, Richardson concludes.