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Sierra Oncology Announces Abstracts Accepted for American Society of Clinical Oncology Annual Meeting

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—New momelotinib analysis examining the association between transfusion independence and overall survival to be presented—

SAN MATEO, Calif., May 19, 2021 May 19, 2021 - Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, today announced three abstracts have been accepted into the program for the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held virtually from June 4-8, 2021.

Association of Transfusion Independence with Improved Overall Survival in Myelofibrosis Patients Receiving Momelotinib

Dr. Ruben Mesa, MD, Director of the Mays Cancer Center, UT Health San Antonio, MD Anderson Cancer Center, will present a poster examining the association between transfusion independence and overall survival for momelotinib patients from SIMPLIFY-1 (JAKi-naïve) and SIMPLIFY-2 (JAKi-exposed).

Previously published data from both SIMPLIFY studies demonstrate robust overall survival for momelotinib-treated patients compared to survival in patients randomized to ruxolitinib (SIMPLIFY-1) or best available therapy (SIMPLIFY-2), followed by momelotinib after week 24 in each (median not yet reached in SIMPLIFY-1 and 34.3 months in SIMPLIFY-2). Additionally, previously reported week 24 transfusion independence rates were higher in the momelotinib arms of SIMPLIFY-1 (67% vs. 49%) and SIMPLIFY-2 (43% vs. 21%). The new analyses suggest JAKi-naïve patients receiving momelotinib who maintain or achieve transfusion independence at week 24 have favorable overall survival compared to non-responders, with a similar trend observed in SIMPLIFY-2.

The full abstract is now available on the ASCO website. Data from this analysis will also be included in an oral presentation at the European Hematology Association Annual Meeting being held virtually June 9-17, 2021.

Presentation Details

Abstract: 7046
Title: Association of transfusion independence with improved overall survival in myelofibrosis patients receiving momelotinib
Presenter: Ruben Mesa, MD
Poster Session Name: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes and Allotransplant
Virtual Presentation Available: Friday, June 4, 2021 beginning at 8:00 am CDT

Two additional momelotinib abstracts were accepted for online publication at ASCO. The first highlights the improved transfusion independence of momelotinib irrespective of baseline degree of anemia, platelet count or transfusion status. The second examines the improvement in longitudinal and individual symptoms for myelofibrosis patients treated with momelotinib in the SIMPLIFY-1 study.

Improved Transfusion Independence Rates for Momelotinib vs. Ruxolitinib in Anemic JAKi Naïve Myelofibrosis Patients Independent of Baseline Platelet or Transfusion Status

Progressive anemia is a common occurrence in myelofibrosis, with nearly all patients requiring transfusions as their disease advances. As described above, the analyses in Abstract 7046 show that JAKi-naïve patients receiving momelotinib who maintain or achieve transfusion independence at week 24 have favorable overall survival compared to non-responders, with a similar trend observed in SIMPLIFY-2. Therefore, it is important to understand which patients are most likely to achieve transfusion independence at week 24.

Abstract e19039 will highlight new analyses from SIMPLIFY-1 to demonstrate that the prognostically important week 24 transfusion independence rates in JAK inhibitor-naïve myelofibrosis patients were consistently higher in anemic patients receiving momelotinib compared to ruxolitinib, regardless of the platelet count, transfusion status or degree of anemia at baseline. Data to be featured further support the potential benefits of inhibiting ACVR1 / ALK2 in addition to JAK1 and JAK2 in myelofibrosis patients, as published 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 full abstract is now available on the ASCO website. Data from this analysis will also be included in a poster presentation at the European Hematology Association Annual Meeting being held virtually June 9-17, 2021.

Presentation Details

Abstract: e19039
Title: Improved Transfusion Independence Rates for Momelotinib vs. Ruxolitinib in Anemic JAKi Naïve Myelofibrosis Patients Independent of Baseline Platelet or Transfusion Status
Presenter: Jean-Jacques Kiladjian, MD, PhD

Longitudinal and Individual Symptom Analyses of Momelotinib and Ruxolitinib Treated Myelofibrosis Patients from SIMPLIFY-1

Previously reported results from the SIMPLIFY-1 study examining momelotinib vs. ruxolitinib in JAKi-naïve myelofibrosis patients did not meet the secondary endpoint of non-inferiority of >50% total symptom score (TSS) reduction at week 24 (momelotinib 28% vs ruxolitinib 42%). Abstract e19040 seeks to better understand the impact of momelotinib relative to ruxolitinib on 7 individual symptom items and the total symptom score (TSS).

Baseline scores across the 7 individual items included in the TSS were heterogenous in both the momelotinib and ruxolitinib groups. Scores for 6 of the 7 items were more severe or very severe (scores 7-10) in the momelotinib arm, relative to ruxolitinib, at baseline. Despite the imbalance in baseline score, item-level health state shifts showed similar improvement for momelotinib and ruxolitinib. Mean TSS improvements were also similar for momelotinib and ruxolitinib. Mean TSS change at week 24 was 6.35 for momelotinib vs. 7.87 for ruxolitinib in the ITT and was 8.80 for momelotinib vs. 10.46 for ruxolitinib in the symptomatic subset. The between-group difference was 1.52 (95% CI: (0.196, 2.847)) in the ITT and 1.67 (95% CI: -0.134, 3.468) in the symptomatic subset.

The comparable item health state shifts at week 24 and similar improvements in mean TSS, with a minimal between-group difference of 1.52 on the 70-point scale, suggest momelotinib provides clinically relevant and comparable symptom improvements to ruxolitinib. The full abstract is now available on the ASCO website.

Presentation Details

Abstract: e19040
Title: Longitudinal and Individual Symptom Analyses of Momelotinib and Ruxolitinib Treated Myelofibrosis Patients from SIMPLIFY-1
Presenter: Ruben Mesa, MD, PhD

About Sierra Oncology
Sierra Oncology is a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer. We harness our deep scientific expertise to identify compounds that target the root cause of disease. Our team takes an evidence-based approach to understand the limitations of current treatments and explore new ways to change the cancer treatment paradigm. Together we are transforming promise into patient impact.

For more information, 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.

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SOURCE Sierra Oncology