RCS - Hutchmed China Ltd - HUTCHMED Data at ASCO GI Cancers Symposium

HUTCHMED (China)Announcement

19/01/2022 07:05

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RNS Number : 8356Y  Hutchmed (China) Limited  19 January 2022

Press Release

 

HUTCHMED Highlights Fruquintinib Clinical Data to be Presented at the 2022 ASCO Gastrointestinal Cancers Symposium

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, January 19, 2022:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX: 13) today announces that updated analysis of the
ongoing international Phase I/Ib trial of fruquintinib will be presented at
the upcoming 2022 ASCO Gastrointestinal Cancers Symposium, taking place on
January 20-22, 2022.  The meeting will be held virtually and in person at the
Moscone Center in San Francisco, California, US.

 

 

Further details of the presentation are as follows:

 

 Title:            Phase I/Ib trial of fruquintinib in patients with advanced solid tumors:
                   preliminary results of the dose expansion cohorts in refractory metastatic
                   colorectal cancer
 Presenter:        Arvind Dasari, MD, MS, MD Anderson Cancer Center
 Session:          Poster Session C: Cancers of the Colon, Rectum, and Anus
 Abstract No.:     93 (https://meetings.asco.org/abstracts-presentations/204754)
 Date & Time:      Saturday, January 22, 2022
 Location:         Moscone Center - West, Level 1, West Hall and virtually

 

About Colorectal Cancer ("CRC")

CRC is a cancer that starts in either the colon or rectum. CRC is the third
most common cancer worldwide, estimated to have caused more than 915,000
deaths in 2020. 1  (#_edn1) In the U.S., an estimated 150,000 people were
diagnosed with CRC and 53,000 people died from CRC in 2021. 2  (#_edn2) In
Europe, CRC is the second most common cancer, with an estimated 507,000 new
cases and 240,000 deaths in 2020.(1) In Japan, CRC is the most common cancer,
with an estimated 147,000 new cases and 59,000 deaths in 2020.(1)

 

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2
and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis.
Fruquintinib was designed to improve kinase selectivity to minimize off-target
toxicities, improve tolerability and provide more consistent target coverage.
The generally good tolerability in patients to date, along with fruquintinib's
low potential for drug-drug interaction based on preclinical assessment,
suggests that it may also be highly suitable for combinations with other
anti-cancer therapies.

 

About Fruquintinib Approval in China

Metastatic CRC in China: Fruquintinib was approved for marketing by the China
National Medical Products Administration (NMPA) in September 2018 and
commercially launched in China in late November 2018 under the brand name
ELUNATE(®). It was included in the China National Reimbursement Drug List
(NRDL) in January 2020. ELUNATE(®) is indicated for the treatment of patients
with metastatic CRC who have been previously treated with fluoropyrimidine,
oxaliplatin and irinotecan, including those who have previously received
anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the
FRESCO study 3  (#_edn3) , a Phase III pivotal registration trial of
fruquintinib in 416 patients with metastatic CRC in China, were published
(https://jamanetwork.com/journals/jama/fullarticle/2685988) in The Journal of
the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov
identifier: NCT02314819 (https://clinicaltrials.gov/ct2/show/NCT02314819) ).

 

About Fruquintinib Development Beyond CRC Monotherapy

The safety and efficacy of fruquintinib for the following investigational uses
have not been established and there is no guarantee that it will receive
health authority approval or become commercially available in any country for
the uses being investigated:

 

Gastric Cancer ("GC") in China: In October 2017, HUTCHMED initiated the
FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the
efficacy and safety of fruquintinib combined with paclitaxel for second-line
treatment of advanced gastric or esophagogastric junction ("GEJ")
adenocarcinoma. The trial is designed to enroll patients who did not respond
to first-line standard chemotherapy. Subjects receive either fruquintinib
combined with paclitaxel or placebo combined with paclitaxel. Patients are
randomized at a 1:1 ratio and stratified according to factors such as stomach
vs. GEJ tumor type and performance status. The primary efficacy endpoint is
overall survival (OS). Secondary efficacy endpoints include progression-free
survival (as defined by RECIST 1.1), objective response rate, disease control
rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version
3.0). Biomarkers related to the antitumor activity of fruquintinib will also
be explored (clinicaltrials.gov identifier: NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) ). In June 2020, HUTCHMED
completed a planned interim data review. Based on the preset criteria, the
Independent Data Monitoring Committee (IDMC) recommended that the trial
continue.

 

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements
to evaluate the safety, tolerability and efficacy of fruquintinib in
combination with PD-1 monoclonal antibodies, including with tislelizumab
(BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by
Innovent Biologics, Inc. and marketed as TYVYT(®) in China).

 

·      Metastatic breast and endometrial cancers in the U.S.: HUTCHMED
initiated this open-label, multi-center, non-randomized, Phase Ib/II study in
the U.S. to assess the safety and efficacy of fruquintinib in combination with
tislelizumab in patients with advanced, refractory triple negative breast
cancer ("TNBC") and endometrial cancer ("EMC"). This study is being conducted
to investigate if the addition of fruquintinib can potentially induce activity
to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of
the study may be found at clinicaltrials.gov, using identifier NCT04577963
(https://clinicaltrials.gov/ct2/show/NCT04577963) . Safety and preliminary
efficacy of fruquintinib were demonstrated in advanced solid tumors, including
TNBC, in a Phase I study conducted in China (NCT01645215
(https://clinicaltrials.gov/ct2/show/NCT01645215) ) and a Phase I/Ib study is
ongoing in the United States (NCT03251378
(https://clinicaltrials.gov/ct2/show/NCT03251378) ).

 

·      Gastric, colorectal and non-small cell lung cancers in China
& Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II
study to assess the safety and efficacy of fruquintinib in combination with
tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or
non-small cell lung cancer ("NSCLC"). Additional details of the study may be
found at clinicaltrials.gov, using identifier NCT04716634
(https://clinicaltrials.gov/ct2/show/NCT04716634) .

 

·      Solid tumors in China: HUTCHMED initiated this open-label,
multi-center, non-randomized, Phase II study to assess the safety and efficacy
of fruquintinib in combination with sintilimab in patients with advanced EMC,
cervical cancer, CRC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell
carcinoma (RCC). Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT03903705
(https://clinicaltrials.gov/ct2/show/NCT03903705) . Preliminary results of
certain cohorts were presented
(https://www.hutch-med.com/csco-2021-highlights/) at the 2021 American Society
of Clinical Oncology Annual Meeting (ASCO) and the Chinese Society of Clinical
Oncology Annual Meeting (CSCO).

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery, global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. It has more than 4,500
personnel across all its companies, at the center of which is a team of over
1,400 in oncology/immunology. Since inception it has advanced 11 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/) .

 

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 fruquintinib for the treatment of patients with
advanced CRC and the further clinical development of fruquintinib in this and
other indications. Forward-looking statements involve risks and uncertainties.
Such risks and uncertainties include, among other things, assumptions
regarding the sufficiency of clinical data to support New Drug Application
approval of fruquintinib for the treatment of patients with advanced CRC in
the U.S., Europe, Japan, Australia or other jurisdictions, its potential to
gain expeditious approvals from regulatory authorities, the safety profile of
fruquintinib, HUTCHMED's ability to fund, implement and complete its further
clinical development and commercialization plans for fruquintinib, the timing
of these events, and the impact of the COVID-19 pandemic on general economic,
regulatory and political conditions. In addition, as certain studies rely on
the use of other drug products such as paclitaxel, tislelizumab and sintilimab
as combination therapeutics with fruquintinib, such risks and uncertainties
include assumptions regarding the safety, efficacy, supply and continued
regulatory approval of these therapeutics. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. For further discussion of these and
other risks, see HUTCHMED's filings with the U.S. Securities and Exchange
Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED
undertakes no 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.

 

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 (mailto: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 (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick                         HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

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

Panmure Gordon (UK) Limited

 

 1  (#_ednref1) The Global Cancer Observatory (https://gco.iarc.fr/) .
Accessed September 21, 2021.

 2  (#_ednref2) SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute.  https://seer.cancer.gov/statfacts/html/colorect.html
(https://seer.cancer.gov/statfacts/html/colorect.html) .  Accessed September
21, 2021.

 3  (#_ednref3) Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo
on Overall Survival in Patients With Previously Treated Metastatic Colorectal
Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496.
doi:10.1001/jama.2018.7855 (https://doi.org/10.1001/jama.2018.7855) .

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