RCS - Hutchmed China Ltd - HMPL-523 Clinical Data Presented at ASH

HUTCHMED (China)Announcement

14/12/2021 07:00

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RNS Number : 5625V  Hutchmed (China) Limited  14 December 2021

Press Release

 

HUTCHMED Highlights HMPL-523 Clinical Data Presented at the 2021 ASH Annual Meeting

 

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, December 14, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces new analyses on the ongoing studies
of HMPL-523 presented at the 63(rd) American Society for Hematology's (ASH)
Annual Meeting and Exposition, held virtually and in person at the Georgia
World Congress Center in Atlanta, Georgia.

 

Further details of the presentations are as follows:

 

 Title:            Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult
                   Patients with Primary Immune Thrombocytopenia: A Randomized, Double-Blind and
                   Placebo-Controlled Phase Ib Study
 Presenter:        Renchi Yang, MD, Hematology Hospital of the Chinese Academy of Medical
                   Sciences
 Session:          311. Disorders of Platelet Number or Function: Clinical and Epidemiological:
                   Treatment of Immune Thrombocytopenia
 Abstract No.:     149895 (https://ash.confex.com/ash/2021/webprogram/Paper149895.html)
 Date & Time:      Saturday, December 11, 2021 9:30am - 11am ET
 Location:         Georgia World Congress Center, C101 Auditorium and virtually

 

As of data cutoff date of September 30, 2021, a total of 34 patients were
randomized to receive HMPL-523 and 11 patients to placebo. Among 16 patients
who were randomized to receive the recommended phase II ("RP2D") dose of 300mg
once daily, 11 patients (68.8%) experienced response as defined by at least
one incident of platelet count being ≥ 50x10(9)/L in the initial 8-week
double blinded phase of the study, compared to one out of 11 patients (9.1%)
randomized to receive placebo. During the subsequent 16-week open-label phase
of the study, one additional patient initially randomized to receive the RP2D
experienced a response. Four patients randomized to placebo crossed over to
receive treatment at RP2D after the initial 8-week double blinded phase of the
study; all four of these patients experienced response. In total, 16 out of 20
patients (80%) experienced response during both phases of the study. Durable
response, defined as platelet count being ≥ 50x10(9)/L in at least 4 out of
6 last scheduled visits, were reported in 8 out of 20 patients (40%) who
received RP2D in both phases of the study.

 

Safety data were presented for all 41 patients who received treatment at all
doses, regardless of whether they were initially randomized to receive active
treatment or crossed over during the open-label extension phase of the study.
The median duration of treatment was 142 days (range: 23-170). No patients
discontinued treatment due to treatment-related adverse events ("TRAE"), and
no cases of treatment-related serious adverse events ("SAE") were reported.
There were 30 patients (73%) who experienced TRAEs, including 3 (7.3%) who
experienced grade 3 or above TRAEs, one of whom received the RP2D. No TRAEs of
grade 3 or above occurred in more than one patient.

 

These results supported the initiation of a Phase III registration study of
HMPL-523 in adult patients with primary immune thrombocytopenia ("ITP"),
ESLIM-01. The first patient in this study received their first dose on October
27, 2021 (https://www.hutch-med.com/eslim-01-phase-iii-trial-initiated/) .
Additional details may be found at clinicaltrials.gov, using identifier
NCT05029635 (https://clinicaltrials.gov/ct2/show/NCT05029635) .

 

 

 Title:            Preliminary Results from a Phase I Study of HMPL-523, a Selective, Oral Syk
                   Inhibitor, in Patients with Relapsed or Refractory Lymphoma
 Presenter:        Paolo Strati, MD, The University of Texas MD Anderson Cancer Center
 Session:          623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical
                   and Epidemio-logical: Poster II
 Abstract No.:     2432 (https://ash.confex.com/ash/2021/webprogram/Paper145641.html)
 Date & Time:      Sunday, December 12, 2021 6:00pm - 8:00pm ET
 Location:         Georgia World Congress Center, Hall B5 and virtually

 

As of data cutoff date of August 25, 2021, 21 patients received a median of
two cycles of treatment (range: 1-19). Among 16 response-evaluable patients, 4
responses were seen in patients in the 400-800 mg cohorts totaling 10
patients. Nine patients experienced disease progression, three in the
400-800mg cohorts and six in the 100-200mg cohorts.

 

Among 21 enrolled patients, 17 (81.0%) patients experienced TRAEs, including 7
(33.3%) who experienced grade 3 or above TRAEs. Specific to TRAE at grade 3 or
above, neutropenia, which occurred in 2 patients, was the only TRAEs of grade
3 or above to have occurred in more than one patient. SAEs were reported in 6
patients (28.6%). Adverse events leading to discontinuation were reported in 2
(9.5%) patients. 7 patients withdrew from the study for reasons other than
progressive disease.

 

These results support progressing HMPL-523 into the ongoing dose expansion
phase of the study to evaluate its safety and efficacy in multiple subtypes of
B-cell and T-cell lymphoma at the R2PD of 700 mg.

 

 

About HMPL-523

 

HMPL-523 is a novel, investigational, selective small molecule inhibitor for
oral administration targeting spleen tyrosine kinase, also known as Syk. Syk
is a major component in B-cell receptor signaling and is an established target
for the treatment of multiple subtypes of B-cell lymphomas and autoimmune
disorders.

 

HUTCHMED currently retains all rights to HMPL-523 worldwide. The ESLIM-01
Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in
treating adult patients with primary ITP, an autoimmune disorder that can lead
to increased risk of bleeding. Additional details may be found at
clinicaltrials.gov, using identifier NCT05029635
(https://clinicaltrials.gov/ct2/show/NCT05029635) . HMPL-523 is also being
studied in indolent non-Hodgkin's lymphoma and multiple subtypes of B-cell
malignancies in China (NCT02857998
(https://clinicaltrials.gov/ct2/show/NCT02857998) ), the U.S. and Europe
(NCT03779113 (https://clinicaltrials.gov/ct2/show/NCT03779113) ). A trial to
study HMPL-523 in patients with warm autoimmune hemolytic anemia (wAIHA),
another autoimmune disorder, is also planned.

 

 

About HUTCHMED

 

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery and global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. It has more than 4,500
personnel across all its companies, at the center of which is a team of over
1,400 in oncology/immunology. Since inception it has advanced eleven cancer
drug candidates from in-house discovery into clinical studies around the
world, with its first three oncology drugs now approved and marketed in China.
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 HMPL-523 for patients, its expectations as to whether
any studies on HMPL-523 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. Forward-looking statements involve risks and uncertainties.
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 HMPL-523, including as a combination therapy, 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 market of HMPL-523 for a targeted indication; the
sufficiency of funding; and the impact of the COVID-19 pandemic on general
economic, regulatory and political conditions. 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.

 

 

CONTACTS

 

 Investor Enquiries
 Mark Lee, Senior Vice President    +852 2121 8200
 Annie Cheng, Vice President        +1 (973) 567 3786

 Media Enquiries
 Americas - Brad Miles,             +1 (917) 570 7340 (Mobile)

Solebury Trout                    bmiles@troutgroup.com (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                    +44 7779 545 055 (Mobile)
                                    HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick

                                    HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,  +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

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