Sierra Oncology to Report Momelotinib Long-term Overall Survival Data in Oral Presentation at ASH 2020

Rhea-AI Summary

Sierra Oncology (SRRA) announced two abstracts on momelotinib, aimed at treating myelofibrosis, to be presented at the 62nd ASH Annual Meeting from December 5-8, 2020. The data may support momelotinib as a unique treatment option, improving anemia, symptoms, and spleen size. Key presentations include long-term survival data from Phase 3 SIMPLIFY trials and comparative efficacy in thrombocytopenic patients. Momelotinib has received Fast Track designation from the FDA, highlighting its potential in addressing significant unmet medical needs in myelofibrosis.

- Efficacy data for momelotinib in myelofibrosis patients by baseline platelet levels also to be presented -

VANCOUVER, BC, Nov. 5, 2020 /PRNewswire/ - Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company focused on the Phase 3 execution, registration and potential commercialization of momelotinib, a novel drug that may address serious unmet needs in myelofibrosis, today announced two abstracts have been selected for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting being held December 5-8, 2020.

"Data presented at this year's ASH annual meeting may support the potential of momelotinib as a unique treatment option for myelofibrosis patients, capable of improving all three hallmarks of disease: anemia, symptoms and spleen," said Barbara Klencke, M.D., Chief Development Officer at Sierra Oncology. "Further, activity is demonstrated in thrombocytopenic patients, regardless of previous treatment with a JAK inhibitor. Collectively, the additional data presented from the SIMPLIFY-1 and SIMPLIFY-2 clinical trials may demonstrate potential long-term survival, and the possibility that more patients may become transfusion independent. A similar clinical profile has not been seen with other agents at this time."

Robust Overall Survival and Sustained Efficacy Outcomes During Long Term Exposure to Momelotinib in JAK Inhibitor Naïve and Previously JAK Inhibitor Treated Intermediate/High Risk Myelofibrosis Patients

Long-term overall survival data from the previously completed SIMPLIFY-1 and SIMPLIFY-2 Phase 3 trials will be reported in an oral presentation by Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas. The trials evaluated JAK inhibitor-naïve and previously JAK inhibitor-treated patients with myelofibrosis who were either randomized to receive momelotinib or were dosed initially with ruxolitinib or best available therapy followed by momelotinib.

Presentation Details

Abstract: 54
Title: Robust Overall Survival and Sustained Efficacy Outcomes During Long Term Exposure to Momelotinib in JAK Inhibitor Naïve and Previously JAK Inhibitor Treated Intermediate/High Risk Myelofibrosis Patients
Presenter: Srdan Verstovsek, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical: New Therapies and JAKi-based Combinations for Myelofibrosis
Session Information: Saturday, December 5, 2020; 7:30 AM - 9:00 AM PT
Presentation Time: 8:15 AM PT

Momelotinib's Spleen, Symptom and Anemia Efficacy is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia

Comparative efficacy data for momelotinib and ruxolitinib in patients with low platelets from SIMPLIFY-1 and SIMPLIFY-2 will be presented in a poster presentation by Jean-Jacques Kiladjian, MD, PhD, Professor of Clinical Pharmacology, Paris Diderot University; Consultant Hematologist, Head, Clinical Investigation Center, Saint Louis Hospital, Paris, France. The presentation will include post-hoc comparative efficacy analyses for momelotinib and ruxolitinib for spleen, symptom and transfusion independence response in patients with baseline platelet counts of <150 x 10⁹/L versus the ITT populations from the two previously completed global Phase 3 SIMPLIFY studies.  A baseline platelet limit of ≥50 × 10⁹/L was required in SIMPLIFY-1 while there was no lower platelet limit for SIMPLIFY-2.  In SIMPLIFY-2, most patients randomized to best available therapy (88%) received ruxolitinib during the randomization period.

Presentation Details

Abstract: 3086
Title: Momelotinib's Spleen, Symptom and Anemia Efficacy is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia
Presenter: Jean-Jacques Kiladjian, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical: Poster III
Session Information: Monday, December 7, 2020; 7:00 AM - 3:30 PM PT

About Sierra Oncology
Sierra Oncology is a late stage biopharmaceutical company focused on the Phase 3 execution, registration and potential commercialization of momelotinib, a novel drug that may address serious unmet needs in myelofibrosis. Momelotinib is a selective and orally bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated mechanism of action that enables it to potentially address all three key drivers of myelofibrosis: anemia of inflammation, constitutional symptoms and enlarged spleen. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 800 patients treated for myelofibrosis. Several of these patients remain on treatment for more than 10 years.

Sierra is enrolling symptomatic and anemic patients, who have been treated previously with a JAK inhibitor in MOMENTUM, a randomized double-blind Phase 3 clinical trial. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib.

For more information, please visit www.sierraoncology.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology's expectations from current data, anticipated clinical development activities, expected timing and success of enrollment of MOMENTUM and potential benefits of momelotinib. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology's cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology's third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading "Risk Factors" set forth in Sierra Oncology's filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

View original content:http://www.prnewswire.com/news-releases/sierra-oncology-to-report-momelotinib-long-term-overall-survival-data-in-oral-presentation-at-ash-2020-301166773.html

SOURCE Sierra Oncology

FAQ

What were the key findings presented about momelotinib by Sierra Oncology at ASH 2020?

At the ASH 2020 meeting, Sierra Oncology highlighted momelotinib's potential to improve anemia, symptoms, and spleen size in myelofibrosis patients, with long-term survival data from the SIMPLIFY trials.

When will the presentations regarding momelotinib take place at the ASH Annual Meeting?

The presentations on momelotinib will occur during the ASH Annual Meeting from December 5-8, 2020.

What is the significance of the SIMPLIFY-1 and SIMPLIFY-2 trials for momelotinib?

The SIMPLIFY-1 and SIMPLIFY-2 trials provide long-term survival data and efficacy outcomes for momelotinib, demonstrating its potential benefits for both JAK inhibitor-naïve and previously treated myelofibrosis patients.

How does momelotinib compare to ruxolitinib for thrombocytopenic patients?

Comparative efficacy data show momelotinib maintaining efficacy in treating spleen size, symptoms, and anemia in thrombocytopenic myelofibrosis patients, unlike ruxolitinib.

What regulatory recognition has Sierra Oncology received for momelotinib?

Sierra Oncology has received Fast Track designation from the FDA for momelotinib, highlighting its potential in treating myelofibrosis.