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Hutchison China Meditech Limited
29 April 2021
Press Release
HUTCHMED Initiates Phase II Registration Study of HMPL--689 in
Patients with Follicular Lymphoma and Marginal Zone Lymphoma in
China
- Single-arm study in 180 patients, with ORR as primary endpoint
-
- Relapsed/refractory FL and MZL constitute approximately 25% of
all NHL -
- HMPL-689 trials are also underway in these and other NHL
subtypes in the U.S., Europe and China -
Hong Kong, Shanghai & Florham Park, NJ - Thursday, April 29,
2021: Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM:
HCM) has initiated a registration-intent Phase II clinical trial of
HMPL--689, its highly selective and potent PI3K inhibitor, in China
in patients with relapsed or refractory follicular lymphoma ("FL")
and marginal zone lymphoma ("MZL"), two subtypes non-Hodgkin's
lymphoma ("NHL"). The first patient was dosed today.
The clinical trial is a multi-center, single-arm, open-label
clinical study to evaluate the efficacy and safety of HMPL-689 once
a day oral monotherapy in approximately 100 patients with
relapsed/refractory FL and approximately 80 patients with
relapsed/refractory MZL. Relapsed/refractory is defined when a
patient has not achieved response (complete response or partial
response) after the latest line of systemic treatment, or has
progressive disease or relapse after achieving response. The
primary endpoint is objective response rate ("ORR"), with secondary
endpoints including complete response rate (CRR), progression-free
survival (PFS), time to response (TTR) and duration of response
(DoR). The trial is being conducted in over 35 sites in China. More
information will be available at clinicaltrials.gov, using
identifier NCT04849351.
The initiation of the Phase II trial is based on the highly
promising preliminary results from the Phase Ib expansion study
ongoing in China, which show that HMPL-689 was well tolerated,
exhibiting dose-proportional pharmacokinetics ("PK"), a manageable
toxicity profile, and single-agent clinical activity in
relapsed/refractory B-cell lymphoma patients. Additional details
may be found at clinicaltrials.gov, using identifier
NCT03128164.
About PI3K and NHL
PI3K (phosphoinositide 3-kinase delta) is a lipid kinase that
controls the activation of several important signaling proteins.
Upon an antigen binding to B-cell receptors, PI3K can be activated
through the Lyn and Syk signaling cascade. The abnormal activation
of B-cell receptor signaling is closely related to the development
of B-cell type hematological cancers, which represent approximately
85% of all NHL cases. Therefore, PI3K is considered to be a
promising target for drugs that aim to prevent or treat hematologic
cancer .
FL accounts for approximately 17% of NHL and MZL accounts for
approximately 8% of NHL. In the U.S., there were estimated 13,000
and 6,000 new cases of FL and MZL in 2020, respectively. In China,
there were estimated 16,000 and 7,000 new cases of FL and MZL in
2020, respectively [1](, [2] , [3]) .
About HMPL-689
HMPL-689 is a novel, selective and potent oral inhibitor
targeting the isoform PI3K . HMPL-689's PK properties are favorable
with good oral absorption, moderate tissue distribution and low
clearance in preclinical PK studies, suggesting a low risk of drug
accumulation and drug-to-drug interaction. Because of its high
target selectivity and optimal PK profile, HMPL-689 has the
potential to demonstrate an optimal benefit-risk profile in this
class.
HUTCHMED has initiated an extensive, globally-focused clinical
development pathway for HMPL-689. In addition to the currently
Phase II trial and the supportive Phase I trial in China, HMPL-689
is also being evaluated in an ongoing Phase I/Ib study in the U.S.
and Europe in patients with relapsed or refractory NHL.
HUTCHMED currently retains all rights to HMPL-689 worldwide.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM) 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. A dedicated organization of over 1,200 personnel has
advanced ten cancer drug candidates from in-house discovery into
clinical studies around the world, with its first two oncology
drugs now approved and launched. 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-689 for patients with FL, MZL and NHL, the
further clinical development for HMPL-689, its expectations as to
whether such studies 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, 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-689, including as a combination
therapy, to meet the primary or secondary endpoint of a study, to
obtain regulatory approval in different jurisdictions, to gain
commercial acceptance after obtaining regulatory approval, the
potential market of HMPL-689 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
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 - Joseph Chi Lo / Zhou Yi, +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Source: NCCN (R) - https://www.nccn.org
[2] Source: SEER -
https://seer.cancer.gov/statfacts/html/follicular.html
[3] Source: GLOBOCAN https://gco.iarc.fr/
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