RCS - Hutchmed China Ltd - HUTCHMED Completes Planned Enrollment of FRESCO-2

HUTCHMED (China)Announcement

06/12/2021 07:00

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RNS Number : 5637U  Hutchmed (China) Limited  06 December 2021

Press Release

 

HUTCHMED Completes Planned Enrollment of FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer

 

- Recruitment of 687 patients globally completed in fifteen months, ahead
of schedule -

- FRESCO-2 primary objective is to confirm overall clinical benefit seen in
the China FRESCO pivotal study 1 , and to support global registrations -

Hong Kong, Shanghai & Florham Park, NJ - Monday, December 6, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX: 13) today announces that it has completed patient
enrollment of FRESCO-2, a Phase III registration study of fruquintinib, an
investigational treatment for the treatment of patients with metastatic
colorectal cancer ("CRC") in the U.S., Europe, Japan and Australia. The
enrollment goal was reached on December 2, 2021.

 

FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial
being conducted in patients with metastatic CRC. The primary endpoint of the
study is overall survival ("OS"). This large Phase III trial enrolled patients
in over 150 sites in 14 countries. Additional details of the study may be
found at clinicaltrials.gov, using identifier NCT04322539
(https://clinicaltrials.gov/ct2/show/NCT04322539) .

 

Dr. Marek Kania, EVP, Managing Director and Chief Medical Officer of HUTCHMED
International Corporation, said, "HUTCHMED continues to execute on developing
novel oncology medicines for patients worldwide despite the backdrop of the
global pandemic. We would like to thank investigators, patients and their
families for taking part in this study and we look forward to seeing the
results of this study in patients with metastatic CRC, where there is a high
unmet need for new treatment options."

 

Topline results from the FRESCO-2 trial are expected to be reported in the
second half of 2022 when the event-driven primary endpoint, OS, is mature. If
positive, HUTCHMED would initiate plans to apply for marketing authorization
of fruquintinib by the U.S. Food and Drug Administration ("FDA"), the European
Medicines Agency ("EMA") and the Japanese Pharmaceuticals and Medical Devices
Agency ("PMDA"). The U.S. FDA granted Fast Track Designation for the
development of fruquintinib for the treatment of patients with metastatic CRC
in June 2020
(https://www.hutch-med.com/fruquintinib-granted-us-fda-fast-track-designation-for-mcrc/)
. Clinical data from the completed Phase III FRESCO study in Chinese patients,
additional supporting studies in CRC and this FRESCO-2 global study, if
positive, could support a future U.S. FDA New Drug Application ("NDA") for the
treatment of patients with advanced metastatic CRC (third-line and later). The
FRESCO-2 study design was also reviewed and endorsed by the EMA and PMDA.

 

HUTCHMED retains all commercial rights to fruquintinib outside of China. In
China, where fruquintinib is marketed under the brand name ELUNATE(®),
HUTCHMED is partnered with Eli Lilly and Company and is responsible for
development and execution of all on-the-ground medical detailing, promotion
and local and regional marketing.  Fruquintinib is not approved for use
outside of China.

 

About 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. 2  In the U.S., an estimated 150,000 people will have been
diagnosed with CRC and 53,000 people will have died from CRC in 2021. 3  In
Europe, CRC is the second most common cancer, with an estimated 507,000 new
cases and 240,000 deaths in 2020.(2) In Japan, CRC is the most common cancer,
with an estimated 147,000 new cases and 59,000 deaths in 2020.(2)

 

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 colorectal cancer 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(1), 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
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
cervical cancer, EMC, 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 eleven 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 NDA 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  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) .

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

 3  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.

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