RCS - Hutchmed China Ltd - Lancet Publish Phase III ESLIM-01 Results

HUTCHMED (China)Announcement

17/06/2024 07:15

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RNS Number : 5960S  Hutchmed (China) Limited  17 June 2024

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 
(#_edn1) 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 (https://www.hutch-med.com/) ") (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
(https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00139-X/abstract)
. 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 (https://clinicaltrials.gov/study/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  (#_edn2)

 

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
(https://www.hutch-med.com/nda-acceptance-in-china-for-sovleplenib-for-the-treatment-of-primary-immune-thrombocytopenia-with-priority-review-status/)
in January 2024. A dose-finding study in the U.S. is being planned
(NCT06291415 (https://www.clinicaltrials.gov/study/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
(https://clinicaltrials.gov/study/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  (#_edn3) ITP is also
associated with fatigue (reported in up to 39% of adults with ITP) and
impaired quality of life. 4  (#_edn4) (, 5  (#_edn5) , 6  (#_edn6) , 7 
(#_edn7) , 8  (#_edn8) ) 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  (#_edn9) 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  (#_edn10)

 

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  (#_edn11) 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  (#_edn12)

 

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 (https://clinicaltrials.gov/study/NCT05535933) ) and indolent
non-Hodgkin's lymphoma (NCT03779113
(https://clinicaltrials.gov/study/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 (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 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                                                    +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 / Rupert Dearden, Panmure Gordon     +44 (20) 7886 2500

 

 1  (#_ednref1)   TPO = Thrombopoietin; TPO-RAs = Thrombopoietin receptor
agonists.

 2  (#_ednref2)   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  (#_ednref3)    Zufferey A, et al. Pathogenesis and Therapeutic
Mechanisms in Immune Thrombocytopenia (ITP). J. Clin. Med. 2017, 6(2), 16.

 4  (#_ednref4)    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  (#_ednref5)    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  (#_ednref6)    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  (#_ednref7)    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  (#_ednref8)    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  (#_ednref9)    Lambert MP, Gernsheimer TB. Clinical updates in adult
immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.

 10  (#_ednref10) Clarivate Landscape & Forecast for Immune
Thrombocytopenic Purpura, 2018.

 11  (#_ednref11) 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  (#_ednref12) 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).

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