On 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, reported three abstracts have been accepted into the program for the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held virtually from June 4-8, 2021 (Press release, Sierra Oncology, MAY 19, 2021, View Source [SID1234580268]).

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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 (Free ASCO Whitepaper) website. Data from this analysis will also be included in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 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 (Free ASCO Whitepaper). 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 (Free ASCO Whitepaper) website. Data from this analysis will also be included in a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 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 (Free ASCO Whitepaper) 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