RCS - Hutchmed China Ltd - HUTCHMED Data to be Presented at EHA2024 Congress
17/05/2024 07:00
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RNS Number : 7864O Hutchmed (China) Limited 17 May 2024
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 (https://www.hutch-med.com/) ") (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 (https://clinicaltrials.gov/study/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 (#_edn1) 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
(https://clinicaltrials.gov/ct2/show/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 Renchi Yang #S316 (https://library.ehaweb.org/eha/2024/eha2024-congress/422420/)
Patients with Primary Immune Thrombocytopenia in China (ESLIM-01): A
Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Oral Presentation (Platelet disorders in the spotlight: Clinical and
Medical Sciences, Tianjin, China translational)
Friday, June 14, 2024
15:00 - 15:15 CEST, Hall Mallo
Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Fengkui Zhang #S297 (https://library.ehaweb.org/eha/2024/eha2024-congress/422401/)
(wAIHA): Results from the Randomized, Double-Blind, Placebo-Controlled, Phase
2 Part of the Study Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Oral Presentation (Thalassemias and rare anemias)
Medical Sciences, Tianjin, China
Sunday, June 16, 2024
12:00 - 12:15 CEST, Hall Mallo
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Patients by Prior Lines Xiaofan Liu #P1629 (https://library.ehaweb.org/eha/2024/eha2024-congress/419716/)
of Therapy: Subgroup Analysis of a Multicenter, Randomized, Double-Blind,
Placebo-Controlled Phase 3 Study (ESLIM-01) Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Poster Session
Medical Sciences, Tianjin, China
Friday, June 14, 2024
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Pts with Prior TPO/TPO-RA Heng Mei #P1631 (https://library.ehaweb.org/eha/2024/eha2024-congress/419718/)
Treatment: Subgroup Analysis of a Multicenter, Randomized, Double-Blind,
Placebo-Controlled Phase 3 Study (ESLIM-01) Union Hospital, Tongji Medical College, Huazhong University of Science and Poster Session
Technology, Wuhan, China
Friday, June 14, 2024
Safety and Efficacy of Syk Inhibitor Sovleplenib in Heavily Pre-Treated Paolo Strati #P1102 (https://library.ehaweb.org/eha/2024/eha2024-congress/419189/)
Hodgkin Lymphoma Patients
The University of Texas MD Anderson Cancer Center, Houston, U.S. Poster Session
Friday, June 14, 2024
HMPL-306 in Patients with Relapsed or Refractory Myeloid Hematological Xiaojun Huang #P532 (https://library.ehaweb.org/eha/2024/eha2024-congress/420596/)
Malignancies Harboring IDH1 and/or IDH2 Mutations: Final Result of Dose
Expansion in Phase 1 Study Peking University People's Hospital, Beijing, China Poster Session
Friday, June 14, 2024
Phase 1 Study of HMPL-306 in Patients with Advanced Acute Myeloid Leukemia Pau Montesinos #P549 (https://library.ehaweb.org/eha/2024/eha2024-congress/420613/)
with Isocitrate Dehydrogenase (IDH) Mutations: Preliminary Results of the Dose
Escalation Cohorts Hospital Universitario La Fe, Valencia, Spain Poster Session
Friday, June 14, 2024
Phase II Study of EZH2 Inhibitor Tazemetostat plus Amdizalisib, a PI3K Mingci Cai #P2080 (https://library.ehaweb.org/eha/2024/eha2024-congress/420167/)
Inhibitor, in Patients with Relapsed/Refractory Lymphomas
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of e-Poster Presentation
Medicine, Shanghai, China
Friday, June 14, 2024
Results from a Phase 1 Dose Escalation Study of HMPL-760, a Third Generation, Ying Qian #P2054 (https://library.ehaweb.org/eha/2024/eha2024-congress/420141/)
Highly Selective, Reversible BTK Inhibitor in Chinese Patients with
Relapsed/Refractory (R/R) Lymphomas Ruijin Hospital affiliated to Shanghai Jiao Tong University School of e-Poster Presentation
Medicine, Shanghai, China
Friday, June 14, 2024
A Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of Waleed Ghanima #PB3341 (https://library.ehaweb.org/eha/2024/eha2024-congress/422107/)
Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia
University of Oslo, Oslo, Norway 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 (https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .
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 (mailto: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
(mailto:HUTCHMED@fticonsulting.com)
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
(mailto:HUTCHMED@brunswickgroup.com)
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon +44 (20) 7886 2500
1 (#_ednref1) TPO = Thrombopoietin; TPO-RAs = Thrombopoietin receptor
agonists.
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