HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)
today announces that it has completed patient enrollment of a
bridging study of tazemetostat in China.
The bridging study is a multicenter, open-label,
Phase II study to evaluate the efficacy, safety and
pharmacokinetics of tazemetostat for the treatment of patients with
relapsed/refractory follicular lymphoma (“R/R FL”). The primary
objective is to evaluate the objective response rate (“ORR”) of
tazemetostat for the treatment of patients with R/R FL whose
disease harbor EZH21 mutations (Cohort 1). The secondary objectives
included duration of response (“DoR”), progression-free survival
(PFS), and overall survival (OS) of tazemetostat for the treatment
of R/R FL patients whose disease do or do not harbor EZH2 mutations
(Cohort 2), as well as to evaluate the safety and pharmacokinetics.
The lead principal investigator is Dr Junning Cao of Shanghai Fudan
University Cancer Center. A total of 42 patients were enrolled.
Additional details may be found at clinicaltrials.gov, using
identifier NCT05467943.
Tazemetostat is a first-in-class
methyltransferase inhibitor of EZH2 developed by Epizyme, Inc.
(“Epizyme”), an Ipsen company. It is approved by the U.S. Food and
Drug Administration (“FDA”) for the treatment of certain patients
with advanced epithelioid sarcoma (“ES”) and certain patients with
R/R FL under the FDA accelerated approval granted in January and
June 2020, respectively. HUTCHMED entered into a strategic
collaboration to research, develop, manufacture and commercialize
tazemetostat in China, Hong Kong, Macau and Taiwan.
In May 2022, tazemetostat was approved by the
Health Commission and Medical Products Administration of Hainan
Province of China to be used in the Hainan Boao Lecheng
International Medical Tourism Pilot Zone (“Hainan Pilot Zone”),
under the Clinically Urgently Needed Imported Drugs scheme, for the
treatment of certain patients with ES and FL consistent with the
label as approved by the FDA.
In March 2023, tazemetostat was approved and
launched in Macau. A market authorization application has been
under review in Hong Kong since December 2022.
Tazemetostat was included in the Chinese Society
of Clinical Oncology (CSCO) guidelines for ES in 2022 and for FL in
2023.
About FL and ES
FL is a subtype of non-Hodgkin’s lymphoma
(“NHL”). FL accounts for approximately 17% of NHL. In 2020, there
were an estimated 16,000 and 13,000 new cases of FL in China and
the U.S., respectively. 2,3,4
ES is a rare, slow-growing type of soft tissue
cancer. Radical tumor resection is the primary treatment for
patients with ES. However, ES is known for its high propensity for
locoregional recurrence and distant metastases. The survival of
patients with ES is often unsatisfactory with very limited
treatment options.5
About
TAZVERIK®
(tazemetostat)
TAZVERIK® is a methyltransferase inhibitor
indicated in the United States for the treatment of:
- Adults and pediatric patients aged
16 years and older with metastatic or locally advanced ES not
eligible for complete resection.
- Adult patients with R/R FL whose
tumors are positive for an EZH2 mutation as detected by an
FDA-approved test and who have received at least two prior systemic
therapies.
- Adult patients with R/R FL who have
no satisfactory alternative treatment options.
These indications are approved under accelerated
approval by the U.S. FDA based on ORR and DoR. Continued approval
for these indications may be contingent upon verification and
description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in
patients with ES are pain, fatigue, nausea, decreased appetite,
vomiting and constipation. The most common (≥20%) adverse reactions
in patients with FL are fatigue, upper respiratory tract infection,
musculoskeletal pain, nausea and abdominal pain.
View the U.S. Full Prescribing Information here:
https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/sites/9/2022/11/03075215/TAZ-US-000213_TAZVERIK-US-PI-1.pdf
TAZVERIK® is approved in Japan with the
indication of relapsed or refractory EZH2 gene mutation-positive FL
(only when standard treatment is not applicable).
TAZVERIK® is a registered trademark of Epizyme
Inc., an Ipsen company.
About Tazemetostat Clinical Development
in China
HUTCHMED and Ipsen are developing tazemetostat
in various hematological and solid tumors in Greater China. We are
participating in Ipsen’s SYMPHONY-1 (EZH-302) study, leading it in
China. We also initiated a Phase ІІ study in combination with our
phosphoinositide 3-kinase delta (PІ3Kδ) inhibitor amdizalisib in
patients with R/R FL in February 2023. We are generally responsible
for funding all clinical trials of tazemetostat in China, including
the portion of global trials conducted there.
SYMPHONY-1 (EZH-302) is an international,
multicenter, randomized, double-blind, active-controlled, 3-stage,
biomarker-enriched, confirmatory Phase 1b/3 study, which is
designed to evaluate the safety and efficacy of tazemetostat in
combination with rituximab + lenalidomide (R2) in patients with R/R
FL after at least one prior line of therapy (clinicaltrials.gov
identifier: NCT04224493).
China combination study in R/R FL is an
open-label, Phase ІІ study in approximately 140 patients to
evaluate the safety, tolerability and preliminary anti-tumor
efficacy of tazemetostat in combination with amdizalisib in
patients with R/R lymphoma. The first patient was dosed in February
2023 (clinicaltrials.gov identifier: NCT05713110).
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
approximately 5,000 personnel across all its companies, at the
center of which is a team of about 1,800 in oncology/immunology.
Since inception it 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 TAZVERIK® for the treatment of patients
with ES or FL, the further clinical development of TAZVERIK® in
this and other indications, risks associated with the use of
TAZVERIK® in the Hainan Pilot Zone and Macau, including that it
could be discontinued in the future for a variety of reasons, the
risk that ongoing or future clinical trials conducted by HUTCHMED
for TAZVERIK® may not meet their primary or secondary endpoints or
will warrant meetings with regulatory authorities, submissions for
regulatory approval or review by governmental authorities under the
accelerated approval process and 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 regulatory approvals, including accelerated approval, to
conduct trials or to market products (including to continue
offering TAZVERIK® in the Hainan Pilot Zone, Macau or elsewhere in
China, Hong Kong and Taiwan), its expectations that preclinical
studies or earlier clinical studies are predictive of the results
of future trials, such as the ongoing confirmatory trials, the
safety profile of TAZVERIK®, the potential for TAZVERIK® to become
a new standard of care for ES or FL patients, HUTCHMED’s and
Epizyme’s ability to implement and complete its further clinical
development plans for TAZVERIK®, the potential commercial launch of
TAZVERIK® in China and other jurisdictions in the approved
indications, the sufficiency of each company's cash resources to
fund its foreseeable and unforeseeable operating expenses and
capital expenditure requirements, the timing of these events, and
the impact of COVID-19 on HUTCHMED’s business, results of
operations and financial condition and on general economic,
regulatory and political conditions. In addition, as certain
studies rely on the use of other drug candidates as combination
therapeutics with TAZVERIK®, such risks and uncertainties include
assumptions regarding the safety, efficacy, supply and regulatory
approval of such drug candidates. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
HUTCHMED anticipates that subsequent events and developments may
cause its views to change; however, HUTCHMED does not undertake any
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. For a further discussion of
these and other risks, see HUTCHMED’s filings with the U.S.
Securities and Exchange Commission, on AIM and with The Stock
Exchange of Hong Kong Limited.
CONTACTS
Investor Enquiries |
|
Mark Lee, Senior Vice President |
+852 2121 8200 |
Annie Cheng, Vice President |
+1 (973) 306 4490 |
|
|
Media Enquiries |
|
Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
/HUTCHMED@fticonsulting.com |
Zhou Yi, Brunswick |
+852 9783 6894 (Mobile)
/HUTCHMED@brunswickgroup.com |
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon |
+44 (20) 7886 2500 |
1 EZH2 = Enhancer of Zeste Homolog 22 Source:
NCCN® – https://www.nccn.org 3 Source: SEER –
https://seer.cancer.gov/statfacts/html/follicular.html 4
Source: GLOBOCAN https://gco.iarc.fr/ 5 Sobanko JF, Meijer L,
Nigra TP. Epithelioid sarcoma: a review and update. J Clin Aesthet
Dermatol. 2009;2(5):49-54.
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