TIDMHCM
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") (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
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.
Additional details may be found at clinicaltrials.gov, using
identifier 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
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. HMPL-523 is also being studied in indolent
non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies
in China (NCT02857998), the U.S. and Europe (NCT03779113). A trial
to study HMPL-523 in patients with warm autoimmune hemolytic anemia
(w AIHA), 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 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 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
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRAGPGCWPUPGUQC
(END) Dow Jones Newswires
December 14, 2021 02:00 ET (07:00 GMT)
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024