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ASH 2023 | Quantifying the anemia benefit of momelotinib in MF: analysis of data from SIMPLIFY-1 & SIMPLIFY-2

Ruben Mesa, MD, Levine Cancer Institute, Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston Salem, NC, discusses the anemia benefit observed with the use of momelotinib in patients with myelofibrosis (MF). Using data from the SIMPLIFY-1 (NCT01969838) and SIMPLIFY-2 (NCT02101268) trials, Dr Mesa explains that patients treated with momelotinib spend less time in a transfusion dependent state than those treated with best available therapy (BAT) or ruxolitinib, highlighting the benefit of this agent. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (edited for clarity)

As we look at the anemia benefit of the recently approved momelotinib JAK1/JAK2 inhibitor for patients with myelofibrosis, we’re trying to better understand and quantify the benefit for patients. And one of those benefits is around becoming transfusion independent, whereas someone might have been transfusion dependent before. And anemia benefit really has two different components. One, less likely to become transfusion dependent from a drug associated adverse event...

As we look at the anemia benefit of the recently approved momelotinib JAK1/JAK2 inhibitor for patients with myelofibrosis, we’re trying to better understand and quantify the benefit for patients. And one of those benefits is around becoming transfusion independent, whereas someone might have been transfusion dependent before. And anemia benefit really has two different components. One, less likely to become transfusion dependent from a drug associated adverse event. So with ruxolitinib there is a percentage of patients who will begin on ruxolitinib and then become more anemic and become transfusion dependent. Alternatively, patients can start with a baseline anemia where they’re transfusion dependent and then become transfusion independent. So we used a novel analysis looking at data from both Phase III trials of momelotinib, both the SIMPLIFY-1 study, which was momelotinib versus ruxolitinib in JAK inhibitor-naive patients, as well as the SIMPLIFY-2 study, which was in ruxolitinib failure patients, momelotinib versus best alternative therapy. Now in that study, many patients still remain on ruxolitinib as best alternative therapy, because that is what they had been selected by their respective physicians.

So in this analysis, we looked at truly kind of an area under the curve type analysis. What is the cumulative time day-by-day that an individual is either in a transfusion dependent state or a transfusion independent state, and was able to show very clearly from both studies, you know, a very significant difference in that transfusion independent period for individuals with myelofibrosis receiving momelotinib versus ruxolitinib. So another way of really quantifying the benefit, the anemia benefit versus ruxolitinib in the frontline and the second-line setting. And this very much matches with the current US guidelines and the US indication that was received for momelotinib, which is for patients with myelofibrosis, with anemia, recognizing that there is a kind of a line agnostic value to it if patients have anemia.

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Disclosures

Leukemia & Lymphoma Society: Membership on an entity’s Board of Directors or advisory committees; AbbVie, CTI, Incyte, Sierra: Consultancy, Honoraria, Research Funding; PharmaEssentia: Research Funding; Blueprint, Bristol Myers Squibb, Genentech, GlaxoSmithKline, Novartis: Consultancy, Honoraria.