Topline findings from the phase 3 MOMENTUM study indicated that patients with myelofibrosis experienced a statistically significant reduction in symptoms following treatment with momelotinib.
Treatment with momelotinib resulted in a statistically significant reduction in symptoms for patients with myelofibrosis, according to a press release of the topline findings from the pivotal phase 3 MOMENTUM trial (NCT04173494).
In a population of 195 patients, specifically 130 who received momelotinib and 65 who received danazol, 25% and 9% of patients, respectively, had a total symptom score of more than 50% (P = .0095). Additionally, 31% of patients in the momelotinib arm and 20% in the control arm were transfusion independent following treatment (one-sided P = .0064), indicating non-inferiority. Investigators also reported a splenic response rate of over 35% in 23% of patients in the experimental arm compared with 3% of patients in the control arm (P = .0006).
The full data are set to be presented at an upcoming medical meeting and plans have been put in place to submit a new drug application for the agent in the second quarter of 2022.
“As a clinician, I am thrilled to see data that confirm the potential of momelotinib as a treatment option for [patients with] myelofibrosis who are anemic or at risk of becoming anemic,” co-principal investigator Ruben Mesa, MD, FACP, executive director at the Mays Cancer Center, UT Health San Antonio, MD Anderson Cancer Center, said in a press release. “Anemia of myelofibrosis is strongly correlated with reduced quality of life and a decrease in overall survival. Half of all myelofibrosis patients present with anemia at diagnosis and virtually all become anemic over time. With currently approved therapies being myelosuppressive, it’s wonderful to know that we may soon have such an effective treatment option for these patients.”
The global, double blind, randomized trial enrolled patients who previously received treatment with a JAK inhibitor approved by the FDA and were anemic and symptomatic. At baseline, patients had a mean total symptom score of 27, hemoglobin of 8 g/dL, and a platelet count of 145x109/L.
Patients were randomized 2:1 to either the momelotinib or danazol cohorts. Patients in the control group were allowed to cross over to the momelotinib arm following 24 weeks of treatment.
Investigators reported that 54% of those in the experimental arm and 65% of those in the control arm had grade 3 or higher adverse effects (AEs). Additionally, serious treatment-emergent AEs were reported in 35% of patients in the momelotinib cohort and 40% in the danazol cohort.
“These data are extremely exciting and everything we had hoped to see from the trial. To achieve statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints while maintaining platelet counts in such a difficult to treat patient population is remarkable, and a confirmation of the anemia response we identified in the comprehensive review of our previous phase 3 studies,” Stephen Dilly, MBBS, PhD, president and chief executive officer at Sierra Oncology, concluded.
Sierra Oncology announces momelotinib achieved statistically significant benefit on symptoms, anemia and splenic size in the pivotal MOMENTUM study for myelofibrosis. News release. Sierra Oncology. January 25, 2022. Accessed January 25, 2022. https://yhoo.it/3nTm7Kg