TIDMHCM
Hutchmed (China) Limited
27 February 2023
Press Release
HUTCHMED Completes Patient Enrollment of Phase II Registration
Trial of Amdizalisib in Follicular Lymphoma in China
Hong Kong, Shanghai & Florham Park, NJ - Monday, February
27, 2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM,
HKEX:13) today announces that it has completed patient enrollment
of Phase II registration trial of amdizalisib in patients with
relapsed or refractory follicular lymphoma ("FL"), a subtype of
non-Hodgkin's lymphoma ("NHL"). The last patient was enrolled on
February 24, 2023.
The clinical trial is a multi-center, single-arm, open-label
clinical study to evaluate the efficacy and safety of amdizalisib
once a day oral monotherapy in patients with relapsed/refractory FL
or marginal zone lymphoma ("MZL"). 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). A total of 108
relapsed/refractory FL patients were enrolled. The trial is being
conducted in over 35 sites in China. Additional details may be
found at clinicaltrials.gov, using identifier NCT04849351.
Topline results on the FL patients in this trial are expected to
be reported in the second half of 2023, followed by submission of
results for presentation at an appropriate medical conference. If
positive, HUTCHMED would initiate plans to apply for marketing
authorization of amdizalisib for relapsed/refractory FL from the
China National Medical Products Administration (NMPA).
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 a 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 Amdizalisib
Amdizalisib (HMPL-689) is a novel, selective and potent oral
inhibitor targeting the isoform PI3K . Amdizalisib's
pharmacokinetic ("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, amdizalisib has the potential
to demonstrate an optimal benefit-risk profile in this class.
In addition to the current Phase II trial and the supportive
Phase I trial in China, amdizalisib is also being evaluated in
combination with tazemetostat (a methyl-trans-ferase inhibitor of
EZH2) in patients with relapsed or refractory lymphoma in a Phase
II study in China.
HUTCHMED currently retains all rights to amdizalisib
worldwide.
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 5,000 personnel across all
its companies, at the center of which is a team of about 1,800 in
oncology/immunology. Since inception, HUTCHMED has focused on
bringing cancer drug candidates from in-house discovery to patients
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 amdizalisib for patients with NHL, the further
clinical development for amdizalisib, 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 amdizalisib, 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 amdizalisib 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, on AIM and on The Stock Exchange of Hong Kong Limited.
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, Solebury Trout +1 (917) 570 7340 (Mobile) / bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
(Mobile) / HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon +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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END
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