REG - Hutchmed China Ltd - FRESCO-2 Study Has Met Primary Endpoint

HUTCHMED (China)Announcement

08/08/2022 07:00

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RNS Number : 1690V  Hutchmed (China) Limited  08 August 2022

HUTCHMED Announces that Fruquintinib Global Phase III FRESCO-2 Study Has Met Its Primary Endpoint in Metastatic Colorectal Cancer

 

- Trial met primary endpoint of overall survival and all secondary
endpoints -

 

- Overall safety consistent with fruquintinib known profile -

 

- Plans for regulatory submissions underway in the U.S., Europe and Japan -

 

- Results to be submitted to an upcoming medical meeting -

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, August 8, 2022: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM: HCM,
HKEX: 13) today announces that the pivotal global Phase 3 FRESCO-2 trial
evaluating the investigational use of fruquintinib met its primary endpoint of
overall survival ("OS") in patients with advanced, refractory metastatic
colorectal cancer ("CRC").

 

The FRESCO-2 study was a multi-regional clinical trial conducted in the U.S.,
Europe, Japan and Australia that investigated fruquintinib plus best
supportive care ("BSC") vs placebo plus BSC in patients with metastatic CRC
who had progressed on standard chemotherapy and relevant biologic agents and
who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In
addition to OS, a statistically-significant improvement in progression-free
survival ("PFS"), a key secondary endpoint, was observed. The safety profile
of fruquintinib in FRESCO-2 was consistent with previously reported studies.
Full results will be submitted for presentation at an upcoming medical
meeting.

 

HUTCHMED has been in communication with regulatory agencies globally regarding
the FRESCO-2 trial design and conduct and will discuss these data with the
agencies in the U.S., Europe and Japan with the intent to submit marketing
authorization applications as soon as possible. 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/)
.

 

"We are very happy to see the positive outcomes of the FRESCO-2 study which
offers a potential new treatment for patients with advanced metastatic
colorectal cancer, where the unmet need is very high and patients have limited
treatment options," said Dr Marek Kania, Executive Vice President, Managing
Director and Chief Medical Officer of HUTCHMED International. "Results from
the global FRESCO-2 study supplement findings from the original FRESCO study
that led to the marketing approval and commercialization of fruquintinib in
China. We would like to thank the patients, their families, and the healthcare
professionals who participated in this study and helped achieve this important
milestone."

 

Professor Cathy Eng, MD, FACP, FASCO, David H. Johnson Endowed Chair in
Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research
Program, at the Vanderbilt-Ingram Cancer Center, who served as the FRESCO2
co-PI and Steering Committee member said: "Completion of the international
FRESCO-2 phase III trial in a timely fashion during the era of COVID-19
isolation demonstrates the unmet need for new therapeutic agents in metastatic
colorectal cancer. By meeting the primary endpoint of OS with a secondary
endpoint of PFS, fruquintinib provides a significant potential new option for
our refractory colorectal cancer patients. As an oral agent, fruquintinib also
provides added convenience for our patients. Based on fruquintinib's profile,
we will likely see further exploration in future clinical trials in different
settings. This is extremely encouraging, and I look forward to seeing the
final results."

 

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of
HUTCHMED, said: "We are pleased to have successfully completed our first
multi-regional clinical trial, FRESCO-2, to support the global registration of
fruquintinib. It has already benefited patients with advanced CRC in China
since its launch in 2018. It is also being evaluated alone and in combination
with other agents in various tumor types in ongoing studies around the world."

 

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. 1  In the U.S., an estimated 151,000 people will have been
diagnosed with CRC and 53,000 people will have died from CRC in 2022. 2  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 has been included in the China National Reimbursement Drug
List (NRDL) since 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 , 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: The FRUTIGA study is a randomized,
double-blind, Phase III trial evaluating the efficacy and safety of
fruquintinib combined with paclitaxel for the treatment of patients with
advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma who did
not respond to first-line standard chemotherapy. Approximately 700 patients
have received either fruquintinib combined with paclitaxel or placebo combined
with paclitaxel. The co-primary efficacy endpoints are OS and PFS
(clinicaltrials.gov identifier: NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) ).

 

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, endometrial, and colorectal cancers in the
U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase
Ib/II study in the U.S. to investigate if the addition of fruquintinib can
potentially induce activity to immune checkpoint inhibitor therapy in
advanced, refractory triple negative breast cancer ("TNBC"), endometrial
cancer, and CRC. 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 as a single agent 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 U.S. (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) .

 

·      Endometrial cancer and other 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, endometrial cancer, GC,
hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC).
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). Following encouraging data in the advanced
endometrial cancer cohort, it has been expanded into a single-arm
registrational Phase II study of over 130 patients. Additional details of the
study may be found at clinicaltrials.gov, using identifier NCT03903705
(https://clinicaltrials.gov/ct2/show/NCT03903705) .

 

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 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/) .

 

Forward-Looking Statements

This announcement 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 timing and outcome of clinical studies and the sufficiency of
clinical data to support NDA approval of fruquintinib for the treatment of
patients with advanced CRC or other indications in the U.S., Europe, Japan,
Australia or other jurisdictions, its potential to gain approvals from
regulatory authorities on an expedited basis or at all, 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
announcement, whether as a result of new information, future events or
circumstances or otherwise.

 

Inside Information

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in
the European Union (Withdrawal) Act 2018).

CONTACTS
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 Annie Cheng, Vice President        +1 (973) 567 3786

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 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

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

Panmure Gordon (UK) Limited

 

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

 2  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 June 27,
2022.

 3  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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