TIDMHCM
Hutchmed (China) Limited
12 September 2023
Press Release
HUTCHMED Completes Patient Enrollment of a Bridging Study of
Tazemetostat in Patients with Relapsed/Refractory Follicular
Lymphoma in China
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, September
12, 2023: 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 EZH2[1]
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(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 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(R) is approved in Japan with the indication of relapsed
or refractory EZH2 gene mutation-positive FL (only when standard
treatment is not applicable).
TAZVERIK(R) 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 study in combination with our
phosphoinositide 3-kinase delta (P 3K ) 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 (R(2) ) 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 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(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 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(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, 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(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 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(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) 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 97 83 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 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.
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 or visit www.rns.com.
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.
END
NRABDGDCBBBDGXB
(END) Dow Jones Newswires
September 12, 2023 02:00 ET (06:00 GMT)
Grafico Azioni Hutchison China Meditech (LSE:0J7G)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Hutchison China Meditech (LSE:0J7G)
Storico
Da Giu 2023 a Giu 2024