Reporting of trials with possible detrimental overall survival: a patient advocate perspective
On Oct 22, 2021, melflufen, a novel peptide–drug conjugate intended for use in relapsed or refractory multiple myeloma, was withdrawn from the US market by the pharmaceutical company that developed it, Oncopeptides, on the basis of possible detrimental overall survival in the group that received melflufen in its confirmatory OCEAN trial. Only a month earlier—and despite an existing US Food and Drug Administration hold due to an increased number of patient deaths in the melflufen group—the same trial had received positive coverage when it was presented at the International Myeloma Workshop (IMW; Sept 8–11, 2021, in Vienna, Austria).