TIDMHCM
RNS Number : 6521Y
Hutchmed (China) Limited
08 September 2022
Press Release
HUTCHMED Highlights Phase III FRESCO-2 MRCT Data Summary of
Fruquintinib in Refractory Metastatic Colorectal Cancer from the
Upcoming ESMO 2022 Presentation
- Fruquintinib treatment reduced the risk of death by 34% in
metastatic colorectal cancer (0.66 HR) -
- Increased disease control with risk of disease progression or death reduced by 68% (0.32 HR) -
- Results to be presented in a late-breaking, proffered paper presentation at ESMO -
- Conference call and webcast to be held on Monday, September 12
at 2:00 pm Paris time to discuss the full trial results and the
unmet medical need in colorectal cancer -
Hong Kong, Shanghai & Florham Park, NJ - T hursday,
September 8, 2022: HUTCHMED (China) Limited ("HUTCHMED")
(Nasdaq/AIM: HCM; HKEX: 13) today announces summary results of the
691-patient, multi-regional clinical trial ("MRCT") of
fruquintinib. These results have been shared in an abstract of the
upcoming presentation at the European Society for Medical Oncology
Congress 2022 ("ESMO22") on September 12, 2022. ESMO22 will be held
at the Paris Expo Porte de Versailles.
Dr Arvind Dasari, Associate Professor, Department of
Gastrointestinal Medical Oncology, The University of Texas MD
Anderson Cancer Center, will present the FRESCO-2 results at
ESMO22. Dr Dasari commented, "These results are exciting and
encouraging for patients and healthcare providers alike since they
address a huge unmet need in refractory metastatic colorectal
cancer. Fruquintinib provides a possible new treatment option with
a meaningful survival benefit and manageable toxicity profile.
These results also offer opportunities for further development of
fruquintinib in other settings and combinations."
The MRCT FRESCO-2 study demonstrated that treatment with
fruquintinib resulted in a statistically significant and clinically
meaningful increase in the primary overall survival ("OS") endpoint
and key secondary progression-free survival ("PFS") endpoint
compared to treatment with placebo. Specifically, the median OS was
7.4 months for the 461 patients treated with fruquintinib compared
to 4.8 months for the 230 patients in the placebo group (hazard
ratio ["HR"] 0.66; 95% confidence interval ["CI"] 0.55-0.80;
p<0.001). Median PFS was 3.7 months for patients treated with
fruquintinib compared to 1.8 months for patients in the placebo
group (HR 0.32; 95% CI 0.27-0.39; p<0.001). The disease control
rate ("DCR") was 55.5% in the fruquintinib group compared to 16.1%
for patients in the placebo group. Median duration of follow-up was
approximately 11 months for patients in both groups.
The safety profile of fruquintinib in FRESCO-2 was consistent
with previously reported fruquintinib studies. Grade 3 or above
adverse events occurred in 62.7% of patients who received
fruquintinib, compared to 50.4% of patients who received placebo.
Grade 3 or above adverse events that occurred in more than 5% of
patients who received fruquintinib were hypertension (13.6% vs 0.9%
in the placebo group), asthenia (7.7% vs 3.9% in the placebo group)
and hand-foot syndrome (6.4% vs 0% in the placebo group).
Further details of the FRESCO-2 presentation at ESMO22 are as
follows:
Title: FRESCO-2: A global Phase 3 multi-regional clinical trial
(MRCT) evaluating the efficacy and safety of fruquintinib
in patients with refractory metastatic colorectal cancer
Session: Proffered Paper session 2: GI, lower digestive
Abstract No.: LBA25
Date & Time: Monday, September 12, 2022, 11:00-11:10 am Paris time
Location: 7.2.F - Fécamp Auditorium
Investor audio webcast and conference call is scheduled on
Monday, September 12 at 2:00 pm Paris Time (1:00 pm London time,
8:00 am New York time, and 8:00 pm Hong Kong time).
Participating on the webcast will be members of the HUTCHMED
management team, Dr Dasari and other co-Principal Investigators
from the study:
-- Dr Cathy Eng, David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center;
-- Dr Josep Tabernero, Head of the Medical Oncology Department
of Vall d'Hebron University Hospital, Barcelona, Spain; Director of
Clinical Research at Vall d'Hebron Institute of Oncology; Head of
the Gastrointestinal and Endocrine Tumors Group; Past President,
the European Society for Medical Oncology;
-- Dr James Yao, Professor, Ellen F. Knisely Distinguished Chair
in Colon Cancer Research, Department of GI Medical Oncology,
Division of Cancer Medicine, MD Anderson Cancer Center, Houston,
TX; and
-- Dr Takayuki Yoshino, Professor, Director Department of
Gastrointestinal Medical Oncology, National Cancer Hospital East,
Chiba, Japan.
Details of the conference call dial-in and the webcast link will
be provided on the company website at www.hutch-med.com/event/. A
replay will also be available on the website shortly after the
event.
About FRESCO-2
The FRESCO-2 study is a 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 colorectal cancer ("CRC"). As
previously disclosed, the 691-patient study met its primary
endpoint of OS 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. Additional details of
the study may be found at clinicaltrials.gov, using identifier
NCT04322539.
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 FRESCO and 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).
The study demonstrated that fruquintinib provided a statistically
significant and clinically meaningful benefit in third-line
metastatic CRC patients in China. Median OS was 9.3 months for
patients treated with fruquintinib, as compared to 6.6 months for
patients in the placebo group (HR 0.65; 95% CI 0.51-0.83;
p<0.001). Median PFS was 3.7 months for patients treated with
fruquintinib, as compared to 1.8 months for patients in the placebo
group (HR 0.26; 95% CI 0.21-0.34; p<0.001). DCR was 62.2% vs.
12.3% for placebo. In terms of safety, results showed that
fruquintinib had a manageable safety profile. The most frequently
reported fruquintinib-related grade 3 and above adverse events
included hypertension (21.2%) and hand-foot skin reaction
(10.8%).
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
(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 (developed by BeiGene, Ltd)
and sintilimab (developed by Innovent Biologics, Inc.).
-- Metastatic breast, endometrial, and CRC 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 GC, 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, 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
(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 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 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
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, Solebury +1 (917) 570 7340 (Mobile) | bmiles@soleburystrat.com
Europe - Ben Atwell / Alex Shaw, FTI +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 (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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