TIDMHCM
Hutchmed (China) Limited
01 August 2022
Press Release
HUTCHMED Initiates a Bridging Study of Tazemetostat in Patients
with Relapsed/Refractory Follicular Lymphoma in China
Hong Kong, Shanghai & Florham Park, NJ - Monday, August 1,
2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated a bridging study of
tazemetostat in China. The first patient received their first dose
on July 29, 2022.
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 efficacy of tazemetostat for treatment of patients
with R/R FL who have mutations in EZH2[1] (Cohort 1). The secondary
objectives are to evaluate the efficacy of tazemetostat for
treatment of patients with R/R FL who have EZH2 wild-type (Cohort
2) and to evaluate the safety and the pharmacokinetics of
tazemetostat for treatment of patients with R/R FL. The lead
principal investigator is Dr Junning Cao of Shanghai Fudan
University Cancer Center. Additional details may be found at
clinicaltrials.gov, using identifier NCT05467943.
Tazemetostat is a methyltransferase inhibitor of EZH2 developed
by Epizyme, Inc. ("Epizyme"). 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.
In August 2021, HUTCHMED entered into a strategic collaboration
with Epizyme 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.
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(R) (tazemetostat)
TAZVERIK(R) 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 epithelioid sarcoma not eligible for
complete resection.
-- Adult patients with relapsed or refractory follicular
lymphoma 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 relapsed or refractory follicular
lymphoma who have no satisfactory alternative treatment
options.
These indications are approved under accelerated approval by the
U.S. FDA based on overall response rate and duration of response.
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
epithelioid sarcoma are pain, fatigue, nausea, decreased appetite,
vomiting and constipation. The most common (>=20%) adverse
reactions in patients with follicular lymphoma are fatigue, upper
respiratory tract infection, musculoskeletal pain, nausea and
abdominal pain.
View the U.S. Full Prescribing Information here:
www.tazverik.com
TAZVERIK(R) is a registered trademark of Epizyme, Inc.
About Tazemetostat Clinical Development in China
HUTCHMED and Epizyme are developing tazemetostat in various
hematological and solid tumors in Greater China, with HUTCHMED
leading the China portion of Epizyme's SYMPHONY-1 study. HUTCHMED
and Epizyme also intend to conduct additional global studies
jointly.
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 R(2) in patients with relapsed or refractory FL
after at least one prior line of therapy (clinicaltrials.gov
identifier: NCT04224493).
We intend to initiate several combination studies of
tazemetostat with HUTCHMED assets.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharma-ceutical company. It is committed to
the discovery and global develop-ment and commercial-ization of
targeted therapies and immuno-therapies for the treatment of cancer
and immuno-logical diseases. It has more than 4,900 personnel
across all its companies, at the center of which is a team of about
1,800 in oncology/immunology. Since inception it has advanced 13
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.
Cautionary Note on 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(R) for the treatment of patients with ES or
FL, the further clinical development of TAZVERIK(R) in this and
other indications, risks associated with the use of TAZVERIK(R) in
the Hainan Pilot Zone, 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(R) 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(R) in the Hainan Pilot Zone or elsewhere in
China, Hong Kong, Macau 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(R) , the potential for
TAZVERIK(R) 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(R) , the potential
commercial launch of TAZVERIK(R) 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 the COVID-19 pandemic 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(R) , 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) 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
[1] EZH2 = Enhancer of Zeste Homolog 2
[2] Source: NCCN(R) - 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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