December 13, 2024
Author(s): Caroline Seymour, Kyle Doherty
Fact checked by: Courtney Flaherty
Momelotinib (Ojjaara) demonstrated improved overall survival (OS) vs best available therapy (BAT) in patients with ruxolitinib (Jakafi)–pretreated myelofibrosis, according to data from a matching-adjusted indirect comparison (MAIC) analysis that were presented at the 2024 ASH Annual Meeting & Exposition.1
Data from an unmatched analysis demonstrated that the median OS favored patients who received momelotinib (n = 383) compared with those who received BAT (n = 267; HR, 0.373; 95% CI, 0.297-0.469; P < .001). In the base case model (model 1), the median OS also favored momelotinib (n = 89) vs BAT (HR, 0.512; HR, 0.358-0.732; P < .001). In the alternative adjustment model (model 2), the median OS again favored momelotinib (n = 117) vs BAT (HR, 0.484; 95% CI, 0.347-0.675; P < .001).
Additionally, patients in the anemia subgroup who received momelotinib (n = 255) experienced a median OS benefit compared with those treated with BAT (n = 174; HR, 0.384; 95% CI, 0.293-0.504; P < .001). Data from model 1 also showed that patients treated with momelotinib in this subgroup (n = 98) achieved a median OS benefit vs those in the BAT arm (HR, 0.542; 95% CI, 0.387-0.759; P < .001). Findings from model 2 demonstrated a median OS benefit with momelotinib (n = 146) vs BAT (HR, 0.487; 95% CI, 0.360-0.660; P < .001).
“[Although] the trials used in this analysis do no provide long-term outcomes, this MAIC suggests that momelotinib may offer a greater OS benefit than BAT in patients with myelofibrosis previously treated with ruxolitinib, both in the overall cohort and the anemic population,” Francesca Palandri, MD, PhD, lead study author and an adjunct professor in the Department of Medical and Surgical Sciences at the University of Bologna in Italy, said in a poster presentation of the data.
In September 2023, the FDA approved momelotinib for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.2 The regulatory decision was supported by findings from the phase 3 MOMENTUM (NCT04173494) and SIMPLIFY-1 trials (NCT01969838).
To conduct their analysis, Palandri and colleagues performed a MAIC analysis comparing patients who received momelotinib during MOMENTUM, SIMPLIFY-1, or the phase 3 SIMPLIFY-2 trial (NCT02101268) with 267 patients who received BAT across 26 European hematology centers in the real-world, retrospective RUX-MF study.1 Notably, the overall study included 1055 patients treated with ruxolitinib across 26 European hematology centers from 2013 until death or the data cutoff of February 2, 2024.