RCS - Hutchmed China Ltd - Enrollment Completed in Phase 2 Amdizalisib trial

HUTCHMED (China)Announcement

27/02/2023 10:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230227:nRSa1295Ra&default-theme=true

RNS Number : 1295R  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 (https://www.hutch-med.com/) ")
(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
(https://www.clinicaltrials.gov/ct2/show/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 PI3Kδ and NHL

PI3Kδ (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, PI3Kδ 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, PI3Kδ 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 PI3Kδ. 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
(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 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 (mailto:bmiles@soleburystrat.com)
                                                   oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                   (mailto:bmiles@soleburystrat.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
                                                   (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                         +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                   (mailto:HUTCHMED@brunswickgroup.com)

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

 

 

 1  Source: NCCN(®) - https://www.nccn.org (https://www.nccn.org)

 2  Source: SEER - https://seer.cancer.gov/statfacts/html/follicular.html
(https://seer.cancer.gov/statfacts/html/follicular.html)

 3  Source: GLOBOCAN - https://gco.iarc.fr/ (https://gco.iarc.fr/)

 

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAGZGZZLNZGFZG