TIDMHCM
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") (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.
"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(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.[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(R) . It has been included in the
China National Reimbursement Drug List (NRDL) since 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[3], 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 : 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).
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, 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. 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) and a Phase I/Ib study is ongoing in the U.S.
(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.
-- 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 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.
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 or follow us on LinkedIn.
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
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] The Global Cancer Observatory. Accessed September 21,
2021.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. 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.
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