Press Release
HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and
Hematological Malignancy Programs Data to be Presented at the
upcoming EHA2024 Congress
Hong Kong, Shanghai
& Florham Park, NJ - Friday, May 17,
2024: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that topline and subgroup results from the
ESLIM‑01 Phase III study of sovleplenib, as well as new and updated
data related to novel investigational hematological malignancy
therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at
the upcoming European Hematology Association ("EHA") Hybrid
Congress, taking place on June 13-16, 2024 in Madrid, Spain and
online.
ESLIM-01 is a randomized, double-blinded,
placebo-controlled Phase III trial in China of sovleplenib in adult
patients with primary Immune Thrombocytopenia ("ITP") who have
received at least one prior line of standard therapy (NCT05029635). In
188 patients randomized to receive oral sovleplenib or placebo,
sovleplenib demonstrated a clinically meaningful early and
sustained durable platelet response in patients with primary ITP
with durable response rate of 48.4% compared to zero with placebo
(p<0.0001). The median time to response was 1.1 weeks with
sovleplenib. It demonstrated a tolerable safety profile with grade
3 or above treatment-emergent adverse events (TEAEs) in 25.4% of
patients with sovleplenib and 24.2% with placebo. Sovleplenib also
significantly improved quality of life in physical functioning and
energy/fatigue (p<0.05).
Most patients were heavily pretreated with a median of
four prior lines of ITP therapy and a majority (71.3%) of the
patients had received prior TPO/TPO-RA[1]
treatment. Further post-hoc subgroup analysis of the study
demonstrated consistent clinical benefits across ITP patients
regardless of prior lines of ITP therapies or prior TPO/TPO-RA
exposure, regardless of TPO/TPO-RA treatment types and number of
prior regimens.
In addition to the promising data in ITP, results from
Phase II part of the ongoing ESLIM-02 Phase II/III study (NCT05535933)
of sovleplenib for warm antibody autoimmune hemolytic anemia
(wAIHA) will also be presented at the congress demonstrating
encouraging hemoglobin (Hb) benefit compared with placebo, with
overall response rate of 43.8% vs. 0% in the first 8 weeks, and
overall response rate of 66.7% during the 24 weeks of sovleplenib
treatment (including patients that crossed over from placebo). A
favorable safety profile was also demonstrated.
Details of the presentations are as follows:
Abstract
title
|
Presenter / Lead
author
|
Presentation
details
|
Efficacy and Safety of The Syk Inhibitor Sovleplenib
(HMPL-523) in Adult Patients with Primary
Immune Thrombocytopenia in China (ESLIM-01): A Randomized,
Double-Blind, Placebo-Controlled Phase 3 Study
|
Renchi
Yang
Institute of Hematology and Blood
Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin,
China
|
#S316
Oral Presentation (Platelet
disorders in the spotlight: Clinical and translational)
Friday, June 14, 2024
15:00 - 15:15 CEST, Hall
Mallo
|
Sovleplenib for the Treatment of Warm
Antibody Autoimmune Hemolytic Anemia (wAIHA): Results
from the Randomized, Double-Blind, Placebo-Controlled, Phase 2 Part
of the Study
|
Fengkui Zhang
Institute of Hematology
and Blood Diseases
Hospital, Chinese Academy of Medical Sciences, Tianjin,
China
|
#S297
Oral Presentation (Thalassemias
and rare anemias)
Sunday, June 16, 2024
12:00 - 12:15 CEST, Hall
Mallo
|
Sovleplenib In Primary Immune Thrombocytopenia
(ITP) Patients by
Prior Lines of Therapy: Subgroup Analysis of a Multicenter,
Randomized, Double-Blind, Placebo-Controlled Phase 3 Study
(ESLIM-01)
|
Xiaofan Liu
Institute of Hematology and Blood
Diseases Hospital, Chinese Academy of Medical Sciences,
Tianjin, China
|
#P1629
Poster Session
Friday, June 14, 2024
|
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Pts with
Prior TPO/TPO-RA Treatment: Subgroup Analysis of a Multicenter,
Randomized, Double-Blind, Placebo-Controlled Phase 3 Study
(ESLIM-01)
|
Heng Mei
Union Hospital, Tongji Medical
College, Huazhong University of Science and Technology, Wuhan,
China
|
#P1631
Poster Session
Friday, June 14, 2024
|
Safety and Efficacy
of Syk Inhibitor Sovleplenib in Heavily
Pre-Treated Hodgkin Lymphoma Patients
|
Paolo Strati
The University of Texas MD Anderson
Cancer Center, Houston, U.S.
|
#P1102
Poster Session
Friday, June 14, 2024
|
HMPL-306 in Patients with Relapsed or
Refractory Myeloid Hematological Malignancies Harboring
IDH1 and/or IDH2 Mutations: Final Result
of
Dose
Expansion in Phase 1
Study
|
Xiaojun Huang
Peking University People's Hospital,
Beijing, China
|
#P532
Poster Session
Friday, June 14, 2024
|
Phase 1 Study of HMPL-306
in Patients with Advanced Acute Myeloid
Leukemia with
Isocitrate
Dehydrogenase (IDH) Mutations: Preliminary
Results of the Dose Escalation Cohorts
|
Pau Montesinos
Hospital Universitario La Fe,
Valencia, Spain
|
#P549
Poster Session
Friday, June 14, 2024
|
Phase II Study of EZH2 Inhibitor Tazemetostat
plus Amdizalisib, a PI3K Inhibitor,
in Patients with Relapsed/Refractory
Lymphomas
|
Mingci Cai
Ruijin
Hospital affiliated to Shanghai Jiao Tong University School
of Medicine, Shanghai, China
|
#P2080
e-Poster Presentation
Friday, June 14, 2024
|
Results from a Phase 1 Dose Escalation Study
of HMPL-760, a Third Generation, Highly
Selective, Reversible BTK Inhibitor in Chinese Patients with
Relapsed/Refractory (R/R) Lymphomas
|
Ying Qian
Ruijin Hospital affiliated to
Shanghai Jiao Tong University School of
Medicine, Shanghai, China
|
#P2054
e-Poster Presentation
Friday, June 14, 2024
|
A
Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of
Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune
Thrombocytopenia
|
Waleed Ghanima
University of Oslo, Oslo,
Norway
|
#PB3341
Publication Only
|
|
|
|
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery, global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has approximately 5,000 personnel across
all its companies, at the center of which is a team of about 1,800
in oncology/immunology. Since inception, HUTCHMED has focused on
bringing cancer drug candidates from in-house discovery to patients
around the world, with its first three medicines marketed in China,
the first of which is also marketed in the U.S. For more
information, please visit: www.hutch‑med.com or follow us on
LinkedIn.
Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the "safe harbor" provisions of
the U.S. Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect HUTCHMED's current expectations
regarding future events, including but not limited to its
expectations regarding the therapeutic potential of sovleplenib,
HMPL-306, HMPL-760 and tazemetostat, the further clinical
development for sovleplenib, HMPL-306, HMPL-760, tazemetostat and
amdizalisib, its expectations as to whether any studies on
sovleplenib, HMPL-306, HMPL-760, tazemetostat and amdizalisib would
meet their primary or secondary endpoints, and its expectations as
to the timing of the completion and the release of results from
such studies. Such risks and uncertainties include, among other
things, assumptions regarding enrollment rates and the timing and
availability of subjects meeting a study's inclusion and exclusion
criteria; changes to clinical protocols or regulatory requirements;
unexpected adverse events or safety issues; the ability of
sovleplenib, HMPL-306, HMPL-760, tazemetostat and amdizalisib,
including as combination therapies, to meet the primary or
secondary endpoint of a study, to obtain regulatory approval in
different jurisdictions and to gain commercial acceptance after
obtaining regulatory approval; the potential markets of
sovleplenib, HMPL-306, HMPL-760 and tazemetostat for a targeted
indication, and the sufficiency of funding. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. For further discussion of these and other risks, see
HUTCHMED's filings with the U.S. Securities and Exchange
Commission, The Stock Exchange of Hong Kong Limited and on AIM.
HUTCHMED undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about
products that may not be available in all countries, or may be
available under different trademarks, for different indications, in
different dosages, or in different strengths. Nothing contained
herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under
development.
CONTACTS
Investor Enquiries
|
+852 2121 8200 /
ir@hutch-med.com
|
|
|
Media Enquiries
|
|
Ben Atwell / Alex Shaw,
FTI Consulting
|
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
|
Zhou Yi, Brunswick
|
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com
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Nominated Advisor
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Atholl Tweedie /
Freddy Crossley / Daphne Zhang,
Panmure Gordon
|
+44 (20) 7886 2500
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