On May 14, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that Dose Intensity and Long-Term Safety data for momelotinib will be presented in two posters at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress taking place from June 11-21, 2020 (Press release, Sierra Oncology, MAY 14, 2020, View Source [SID1234557992]).

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"In these new analyses of data from the previously completed Phase 3 SIMPLIFY studies, momelotinib displayed favorable long-term efficacy, safety and tolerability consistent with its differentiated pharmacological and clinical profile. These data reinforce the remarkable durability of momelotinib treatment, which was achieved while maintaining sustained active and well tolerated dose intensity," said Dr. Barbara Klencke, Chief Development Officer of Sierra Oncology. "Specifically, momelotinib showed an absence of significant rates of high-grade hematological and other toxicities, which reinforce the compound’s potential to safely and effectively address the unmet needs of patients with intermediate/high risk myelofibrosis. Importantly, no new safety signals or evidence of cumulative toxicity were observed during extended momelotinib daily dosing."

"Momelotinib’s demonstrable anemia benefits facilitate sustained dose intensity and prolonged clinical activity across the continuum of JAK inhibitor naïve and previously JAK inhibitor treated myelofibrosis patients. These properties are in stark contrast to ruxolitinib, where progressive dose reductions due to induced or exacerbated myelosuppression are common, resulting in markedly diminished dose intensity compared to momelotinib," said Dr. Mark Kowalski, Chief Medical Officer of Sierra Oncology. "Critically, patients who subsequently switched from ruxolitinib treatment to momelotinib achieved an immediate and sustained improvement in both hemoglobin and platelets, and generally went on to receive full-dose momelotinib over an extended period, affirming momelotinib’s potential to successfully treat myelofibrosis patients with JAKi-induced hematological toxicity."

The long-term safety data and dose intensity data to be reported at EHA (Free EHA Whitepaper) draw from the extensive clinical dataset available for momelotinib from the two previously conducted SIMPLIFY Phase 3 studies and their subsequent ongoing extended treatment periods. The SIMPLIFY-1 trial was conducted in JAKi-naïve myelofibrosis patients (n=432) randomized 1:1 to momelotinib or ruxolitinib. SIMPLIFY-2 was conducted in prior ruxolitinib-treated myelofibrosis patients with hematological toxicity (n=156) randomized 2:1 to momelotinib or best available therapy (consisting of ruxolitinib in 88% of patients). Patients randomized to ruxolitinib in SIMPLIFY-1 and best available therapy in SIMPLIFY-2 were eligible to cross-over to momelotinib at the end of the 24-week randomized treatment period in both studies, subsequently receiving momelotinib for an extended treatment period.

Sierra is currently enrolling patients in the MOMENTUM clinical trial for patients with myelofibrosis. The randomized double-blind global Phase 3 trial is designed to confirm the efficacy of momelotinib on myelofibrosis symptoms, transfusion independence and splenomegaly, as compared to danazol. The trial is targeting enrollment of 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; 2-sided alpha of 0.05). Data from MOMENTUM, along with data from more than 820 myelofibrosis patients previously treated with momelotinib in prior clinical studies, will form the basis of the global registration strategy for momelotinib.

About the EHA (Free EHA Whitepaper) Posters
Title: Long term Safety of Momelotinib in JAKi Naïve and Previously JAKi Treated Intermediate/High Risk Myelofibrosis Patients
Lead Author: Prof. Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, London, United Kingdom
Session Title: Myeloproliferative neoplasms – Clinical
Poster No.: EP1113

Title: Momelotinib Dose-Intensity is Maintained in JAKi Naïve and Previously JAKi Treated Intermediate/High Risk Myelofibrosis Patients
Lead Author: Dr. Vikas Gupta, Princess Margaret Cancer Centre, Toronto, ON, Canada
Session Title: Myeloproliferative neoplasms – Clinical
Poster No.: EP1103

The accepted abstracts are now available online on the EHA (Free EHA Whitepaper) conference websites at View Source

Both e-posters will be made available through the on-demand Virtual Congress platform and at www.sierraoncology.com as of Friday, June 12, 08:30 CEST.