RCS - Hutchmed China Ltd - Patient Enrollment Completed for Bridging Study

HUTCHMED (China)Announcement

12/09/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230912:nRSL0498Ma&default-theme=true

RNS Number : 0498M  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 (https://www.hutch-med.com/) ")
(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 (https://clinicaltrials.gov/ct2/show/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
(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 (R(2)) in patients
with R/R FL after at least one prior line of therapy (clinicaltrials.gov
identifier: NCT04224493 (https://clinicaltrials.gov/ct2/show/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
(https://clinicaltrials.gov/ct2/show/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 (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 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
                                                                       (mailto:HUTCHMED@fticonsulting.com)
    Zhou Yi, Brunswick                                                 +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                       (mailto: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(®) - 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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRABDGDCBBBDGXB