TIDMHCM
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") (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.
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. 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(R) , 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(R) . It was included in
the China National Reimbursement Drug List (NRDL) in January 2020.
ELUNATE(R) 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 in The Journal of the
American Medical Association, JAMA, in June 2018
(clinicaltrials.gov identifier: 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 fru quintinib combined
with paclitaxel for second-line treatment of advanced g astric or
esophagogastric junction ("GEJ") a denocarcinoma. 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). 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(R) 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. Safety and preliminary efficacy of
fruquintinib were demonstrated in advanced solid tumors, including
TNBC, in a Phase I study conducted in China (NCT01645215) and a
Phase I/Ib study is ongoing in the United States (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.
-- 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. Preliminary results of certain cohorts were
presented 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 or follow us on LinkedIn.
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
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[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.
[2] The Global Cancer Observatory. Accessed September 21,
2021.
[3] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/colorect.html .
Accessed September 21, 2021.
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