RCS - Hutchmed China Ltd - HUTCHMED Initiates Bridging Study of Tazemetostat

HUTCHMED (China)Announcement

01/08/2022 07:16

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220801:nRSA3948Ua&default-theme=true

RNS Number : 3948U  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 (https://www.hutch-med.com/) ") (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
(https://clinicaltrials.gov/ct2/show/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(®) (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 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
(http://www.tazverik.com)

 

TAZVERIK(®) 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 (https://clinicaltrials.gov/ct2/show/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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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(®) 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, 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 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(®), 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 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(®), 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) /

FTI Consulting                    +44 7779 545 055 (Mobile)
                                    HUTCHMED@fticonsulting.com
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick                         HUTCHMED@brunswickgroup.com

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

Panmure Gordon (UK) Limited

 

 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/)
.

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  NRAZZGGRKMDGZZG