Press Release
HUTCHMED Highlights Publication of Phase III ESLIM-01 Results
in The Lancet Haematology
- Publication shows treatment demonstrated
durable response rate of 48.4% vs. 0% with placebo -
- Presentations at EHA showcased subgroup
analyses demonstrating consistent benefits regardless of prior
lines of therapies or prior TPO/TPO-RA[1]
exposure -
- Data supported regulatory submission in China
accepted in January 2024 -
Hong Kong, Shanghai
& Florham Park, NJ - Monday, June
17, 2024: HUTCHMED
(China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that results from ESLIM-01, HUTCHMED's
Phase III trial of sovleplenib (HMPL-523), in adult patients with
primary immune thrombocytopenia ("ITP") in China, were published in
The Lancet Haematology. Additional details and subgroup results
of the study were also presented on June 14 at the European
Hematology Association ("EHA") 2024 Hybrid Congress as an oral and
two poster presentations.
Sovleplenib is a novel, selective, oral inhibitor
targeting spleen tyrosine kinase ("Syk") for the treatment of
hematological malignancies and immune diseases. Syk is a component
in Fc receptor ("FcR") and B-cell receptor signaling pathway. ITP
is a complex autoimmune bleeding disorder, leading to a reduced
platelet level in the peripheral blood. ITP can also impact on
patients' quality of life due to fatigue, restrictions on
activities and anxiety. The ESLIM-01 trial results published by
The Lancet Haematology suggest that
sovleplenib could be a potential treatment option for patients with
ITP who received at least one prior therapy.
ESLIM-01 is a 2:1 randomized, double-blind, Phase III
study conducted in 188 adult patients with primary ITP who had
received at least one previous anti-ITP treatment (NCT05029635).
The study demonstrated a clinically meaningful early and sustained
durable platelet response in patients with primary ITP, with a
tolerable safety profile and improvement in quality of life. The
primary endpoint was met, with durable response rate of 48.4%
(61/126) with sovleplenib compared to zero with placebo
(p<0.0001), which was
consistent across most pre‑defined subgroups. In addition, overall
response rates were 68.3% at 0-12 weeks and 70.6% at 0-24 weeks
with sovleplenib, compared to 14.5% and 16.1% with placebo
(p<0.0001). The median
time to response was 8 days with sovleplenib compared to 30 days
with placebo.
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, including TPO/TPO-RA treatment types and number of prior
regimens. Most patients were heavily pretreated with a median of
four prior lines of ITP therapy. In patients who received four or
more prior lines of therapy, the durable response rate was 47.7%
with sovleplenib compared to 0% with placebo (p<0.0001). In addition, a majority
of the patients had received prior TPO/TPO-RA. 74.6% of patients in
the sovleplenib group had received prior treatment with TPO/TPO-RA,
and analysis in this subgroup also demonstrated a significantly
higher durable response rate of 46.8% with sovleplenib compared to
zero with placebo (p<0.0001).
The safety profile of sovleplenib in ESLIM-01 was
consistent with previously reported studies. The majority of
treatment-emergent adverse events ("TEAEs") were mild or moderate
in severity (grade 1 or 2). Grade 3 or above TEAEs were reported 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).[2]
The China National Medical Products Administration
("NMPA") granted Breakthrough Therapy designation for this
indication and
accepted the New Drug Application ("NDA") for review with Priority
Review in January 2024. A dose-finding study in the U.S. is
being planned (NCT06291415).
HUTCHMED also initiated the registration stage of the Phase II/III
clinical trial of sovleplenib in adult patients with warm antibody
autoimmune hemolytic anemia ("wAIHA") in China in March 2024
(NCT05535933).
HUTCHMED retains all rights to sovleplenib worldwide.
About ITP
ITP is an autoimmune disorder characterized by
immunologic destruction of platelets and decreased platelet
production. Patients with ITP are at increased risk of excessive
bleeding and bruising.[3] ITP is also
associated with fatigue (reported in up to 39% of adults with ITP)
and impaired quality of life.[4],[5],[6],[7],[8] The incidence of primary ITP in adults is
3.3/100,000 adults per year with a prevalence of 9.5 per 100,000
adults.[9] Based on this prevalence rate,
approximately 110,000 patients are estimated to be living with
primary ITP in China, in addition to 56,000 patients in the U.S.,
Germany, France, Italy, Spain, UK, and Japan. It has been estimated
that as many as 145,000 patients are living with chronic ITP in
major pharmaceutical markets excluding China.[10]
Adult ITP is a heterogeneous disease that can persist
for years, even with best available care, and treatments are
infrequently curative. Despite availability of several treatments
with differing mechanisms of action, chronicity of disease
continues to be a problem. Many patients develop resistance to
treatment and thereby are prone to relapse.[11] Thus, there remains a significant population of
patients who have limited sensitivity to currently available agents
and are in need of new treatments.
As platelet destruction in ITP is mediated by
Syk-dependent phagocytosis of FcγR-bound platelets, Syk inhibition
represents a promising approach to management of ITP.[12]
About Sovleplenib
Sovleplenib is a novel, selective inhibitor of Syk for
once daily oral administration. Syk, a non-receptor tyrosine
kinase, is a major component in B-cell receptor and FcR signaling
and is an established target for the treatment of multiple subtypes
of B-cell lymphomas and autoimmune disorders.
Sovleplenib is currently under clinical investigation
and its safety and efficacy have not been approved by any
regulatory authority.
HUTCHMED retains all rights to sovleplenib worldwide.
In addition to ITP, sovleplenib is also being studied in warm
antibody autoimmune hemolytic anemia (NCT05535933) and
indolent non-Hodgkin's lymphoma (NCT03779113).
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 it has focused on bringing
cancer drug candidates from in-house discovery to patients around
the world, with its first three oncology 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 its expectations regarding the
therapeutic potential of sovleplenib for the treatment of patients
with ITP and the further development of sovleplenib in this and
other indications. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding the timing and outcome of clinical
studies and the sufficiency of clinical data to support NDA
approval of sovleplenib for the treatment of patients with ITP or
other indications in China or other jurisdictions, its potential to
gain approvals from regulatory authorities on an expedited basis or
at all, the safety profile of sovleplenib, HUTCHMED's ability to
fund, implement and complete its further clinical development and
commercialization plans for sovleplenib, and the timing of these
events. 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
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+852 2121 8200 /
ir@hutch-med.com
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Media Enquiries
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Ben Atwell / Alex Shaw,
FTI Consulting
|
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
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Zhou Yi, Brunswick
|
+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
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Nominated Advisor
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Atholl Tweedie / Freddy
Crossley / Rupert
Dearden, Panmure Gordon
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+44 (20) 7886 2500
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[1] TPO = Thrombopoietin;
TPO-RAs = Thrombopoietin receptor agonists.
[2] Hu Y, et al. 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
[published online ahead of print, 2024 Jun 14]. Lancet Haematol. 2024.
[3] Zufferey A, et al.
Pathogenesis and Therapeutic Mechanisms in Immune Thrombocytopenia
(ITP). J. Clin. Med. 2017,
6(2), 16.
[4] McMillan R, et al.
Self-reported health-related quality of life in adults with chronic
immune thrombocytopenic purpura. Am J Hematol. 2008
Feb;83(2):150-4.
[5] Snyder CF, et al.
Health-related quality of life of immune thrombocytopenic purpura
patients: results from a web‑based survey.
Curr Med Res Opin. 2008
Oct;24(10):2767-76.
[6] Doobaree IU, et al.
Thromboembolism in adults with primary immune thrombocytopenia: a
systematic literature review and meta-analysis. Eur J Haematol. 2016
Oct;97(4):321-30.
[7] Sarpatwari A, et al.
Thromboembolic events among adult patients with primary immune
thrombocytopenia in the United Kingdom General Practice Research
Database. Haematologica.
2010 Jul;95(7):1167-75.
[8] Sarpatwari A, et al.
Health-related lifestyle in adults and children with primary immune
thrombocytopenia (ITP). Br J
Haematol. 2010 Oct;151(2):189-91.
[9] Lambert MP, Gernsheimer
TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May
25;129(21):2829-2835.
[10] Clarivate Landscape &
Forecast for Immune Thrombocytopenic Purpura, 2018.
[11] Provan D, et al. Updated
international consensus report on the investigation and management
of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817.
[12] Crowley MT, et al. A
critical role for Syk in signal transduction and phagocytosis
mediated by Fcγ receptors on macrophages. J. Exp. Med. 186(7), 1027-1039
(1997).