TIDMHCM
RNS Number : 2216G
Hutchmed (China) Limited
14 November 2022
HUTCHMED Announces Positive Topline Result in Fruquintinib Phase
III FRUTIGA Study in Second-Line Gastric Cancer in China
- Results of dual primary endpoint study showed statistically
significant and clinically meaningful benefit in progression-free
survival, a primary endpoint -
- Overall survival, the other primary endpoint, was not
statistically significant -
- Safety findings consistent with fruquintinib known profile
-
Hong Kong, Shanghai & Florham Park, NJ - Monday, November
14, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM,
HKEX: 13) today announces initial results from FRUTIGA, a Phase III
study of fruquintinib combined with paclitaxel in 703 Chinese
patients with advanced gastric or gastroesophageal junction ("GEJ")
adenocarcinoma.
The trial was positive, having met one of the primary endpoints
of statistically significant improvement in progression-free
survival ("PFS"), which is clinically meaningful. The other primary
endpoint of overall survival ("OS") was not statistically
significant per the pre-specified statistical plan, although there
was an improvement in median OS. Fruquintinib also demonstrated a
statistically significant improvement in secondary endpoints
including objective response rate (ORR), disease control rate
(DCR), and improved duration of response (DoR). The safety profile
of fruquintinib in FRUTIGA was consistent with previously reported
studies.
Full detailed results are subject to ongoing analysis and are
expected to be disclosed at an upcoming scientific meeting. These
results as well as further analyses will be shared with the China
National Medical Products Administration ("NMPA").
"The combination of fruquintinib and paclitaxel demonstrated
significant clinical benefits for these patients in controlling
this disease. Our team will continue to analyze the data and
discuss these findings with the NMPA for possible NDA filing," said
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer
of HUTCHMED.
Professor Rui-Hua Xu, MD, President of the Sun Yat-Sen
University Cancer Center, who served as the FRUTIGA lead principal
investigator and Steering Committee Chairman, said: "By meeting the
primary endpoint of PFS, fruquintinib demonstrated consistent
efficacy and safety in gastric cancer indication in addition to its
approved colorectal cancer indication. I am extremely excited that
fruquintinib may provide a potential new oral treatment option for
second line gastric cancer patients based on the FRUTIGA
trial."
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.
HUTCHMED 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 FRUTIGA and Gastric Cancer
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:
The FRUTIGA study is a randomized, double-blind, Phase III study
in China to evaluate fruquintinib combined with paclitaxel compared
with paclitaxel monotherapy, for second-line treatment of advanced
gastric cancer or GEJ adenocarcinoma. The trial enrolled patients
who did not respond to first-line standard chemotherapy. Patients
were randomized at a 1:1 ratio and stratified according to factors
such as stomach vs. GEJ tumor type and performance status.
Additional details about this study can be found at
clinicaltrials.gov, using identifier NCT03223376.
Gastric cancer is the fourth leading cause of cancer death
worldwide. Over one million new cases of gastric cancer and
approximately 769,000 deaths were estimated in 2020 worldwide, with
the highest incidence rates in several Eastern Asian countries. In
2020, there were 478,500 new gastric cancer cases and 331,600
deaths estimated in China. [1] Due to late-onset symptoms, gastric
cancer is often diagnosed at an advanced stage with poor prognosis
and limited treatment options.
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 ("CRC") in China: Fruquintinib was
approved for marketing by the NMPA in September 2018 and
commercially launched in China in 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 [2] , 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 (NCT02314819).
About Other Fruquintinib Development
Metastatic CRC in the U.S., Europe, Japan and Australia: The
FRESCO-2 study is a multi-regional clinical trial ("MRCT")
conducted in the U.S., Europe, Japan and Australia that
investigated fruquintinib plus best supportive care ("BSC") vs
placebo plus BSC in patients with advanced, refractory metastatic
CRC. The results were recently presented at the European Society
for Medical Oncology Congress 2022. The MRCT FRESCO-2 study
demonstrated that treatment with fruquintinib resulted in a
statistically significant and clinically meaningful increase in the
primary OS endpoint and key secondary PFS endpoint compared to
treatment with placebo. The safety profile of fruquintinib in
FRESCO-2 was consistent with previously reported fruquintinib
studies. We plan to complete new drug application filings in the
U.S., Europe and Japan in 2023 (NCT04322539 ). The U.S. FDA granted
Fast Track Designation for the development of fruquintinib for the
treatment of patients with metastatic CRC in June 2020.
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 (developed by BeiGene, Ltd)
and sintilimab (developed by Innovent Biologics, Inc.).
-- 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
(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 ("NSCLC")
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 gastric cancer, CRC or NSCLC
(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, gastric cancer, 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 (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
gastric cancer 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
gastric cancer or other indications in China 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, Solebury Trout +1 (917) 570 7340 (Mobile) / bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
(Mobile) / HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon +44 (20) 7886 2500
[1] Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics
2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for
36 Cancers in 185 Countries. CA Cancer J Clin. 2021;
71(3):209-49.
[2] 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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END
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