TIDMHCM
RNS Number : 9757C
Hutchmed (China) Limited
16 June 2023
Press Release
HUTCHMED and Takeda Announce Publication of Phase III FRESCO-2
Results in The Lancet
- Publication shows FRESCO-2 demonstrated treatment with
fruquintinib reduced the risk of death by 34% in previously treated
metastatic colorectal cancer (0.66 HR) -
- Data support regulatory submissions in the U.S., Europe and
Japan during 2023 -
Hong Kong, Shanghai, Florham Park, NJ, Osaka, Japan &
Cambridge, MA - Friday, June 16, 2023: HUTCHMED (China) Limited
("HUTCHMED") (Nasdaq/AIM: HCM, HKEX: 13) and Takeda (TSE:4502,
NYSE:TAK) today announced that results of the Phase III FRESCO--2
study evaluating fruquintinib in patients with previously treated
metastatic colorectal cancer ("CRC") were published in The
Lancet.
The publication provides details of the FRESCO-2 study results
as of June 24, 2022. Summary results from this cut-off date were
presented on September 12, 2022, at the European Society for
Medical Oncology Congress 2022 ("ESMO22").
Fruquintinib is a highly selective and potent inhibitor of
vascular endothelial growth factor receptors ("VEGFR") -1, -2 and
-3. FRESCO-2 is a global Phase III multi-regional clinical trial
(MRCT) conducted in the U.S., Europe, Japan and Australia
investigating fruquintinib plus best supportive care ("BSC") vs
placebo plus BSC in patients with previously treated metastatic
CRC. The FRESCO-2 study met its primary and key secondary
endpoints, demonstrating that treatment with fruquintinib resulted
in a statistically significant and clinically meaningful
improvement in overall survival ("OS") and progression-free
survival ("PFS"), respectively. The safety profile of fruquintinib
in FRESCO-2 was consistent with previously reported fruquintinib
studies.
FRESCO-2 was a key study supporting regulatory submissions to
the U.S. Food and Drug Administration ("FDA") for fruquintinib for
the treatment of previously treated metastatic CRC, which was
accepted for review and granted Priority Review in May 2023. Filing
of a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) and an NDA to the Japan Pharmaceuticals and
Medical Devices Agency (PMDA) are planned in 2023.
In March 2023, HUTCHMED and Takeda closed an exclusive license
agreement to further the global development, commercialization and
manufacture of fruquintinib outside of China.
About CRC
CRC is a cancer that starts in either the colon or rectum.
According to the International Agency for Research on Cancer, CRC
is the third most prevalent cancer worldwide, associated with more
than 935,000 deaths in 2020. [1] In the U.S., it is estimated that
153,000 patients will be diagnosed with CRC and 53,000 deaths from
the disease will occur in 2023. [2] In Europe, CRC was the second
most common cancer in 2020, with approximately 520,000 new cases
and 245,000 deaths. In Japan, CRC was the most common cancer, with
an estimated 148,000 new cases and 60,000 deaths in 2020.(1)
Although early-stage CRC can be surgically resected, metastatic CRC
remains an area of high unmet need with poor outcomes and limited
treatment options. Some patients with metastatic CRC may benefit
from personalized therapeutic strategies based on molecular
characteristics; however, most patients have tumors that do not
harbor actionable mutations. [3](, [4] , [5] , [6] , [7])
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 with the intention of minimizing off-target
toxicities, improving tolerability and providing more consistent
target coverage. Fruquintinib has been generally well tolerated in
patients to date and is being investigated in combinations with
other anti-cancer therapies.
About Fruquintinib Approval in 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 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). Approval in China
is supported by the results of the FRESCO study, a Phase III
pivotal registration trial of fruquintinib in 416 patients with
metastatic CRC in China, published in The Journal of the American
Medical Association, JAMA, in June 2018 (NCT02314819). [8]
HUTCHMED markets fruquintinib in China in partnership with Eli
Lilly and Company.
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.
About the FRESCO-2 Phase III Trial in CRC Outside of China
The FRESCO-2 study is a multi-regional clinical trial conducted
in the U.S., Europe, Japan and Australia investigating fruquintinib
plus BSC vs placebo plus BSC in patients with previously treated
metastatic CRC (NCT04322539 ). The study met its primary and key
secondary endpoints, demonstrating that treatment with fruquintinib
resulted in a statistically significant and clinically meaningful
improvement in OS and PFS, respectively. Results from the study
were presented at ESMO22 in September 2022 and subsequently
published in The Lancet. [9](, [10])
The median OS was 7.4 months for the 461 patients treated with
fruquintinib compared with 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). The median PFS was 3.7 months for
patients treated with fruquintinib compared with 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 56% in the
fruquintinib group compared with 16% for patients in the placebo
group (95% CI, 32.8-46.0; p<0.001). 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 higher
adverse events occurred in 63% (286/456) of patients who received
fruquintinib plus BSC, compared to 50% (116/230) of patients who
received placebo plus BSC. Grade 3 or higher adverse events that
occurred in >= 5% of patients who received fruquintinib were
hypertension (14% vs 1% in the placebo group), asthenia (8% vs 4%
in the placebo group) and hand-foot syndrome (6% vs 0% in the
placebo group). Adverse events leading to discontinuation occurred
in 20% of patients who received fruquintinib, compared to 21% of
patients who received placebo.
About Other Fruquintinib Developments
Gastric Cancer in China: 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
gastroesophageal junction adenocarcinoma (NCT03223376). Topline
results were announced in November 2022. The trial met one of the
primary endpoints of statistically significant improvement in PFS,
which is clinically meaningful. The other primary endpoint of OS
was not statistically significant per the pre-specified statistical
plan, although there was a numerical improvement in median OS.
Fruquintinib also demonstrated a statistically significant
improvement in secondary endpoints including objective response
rate (ORR), DCR, and improved duration of response (DoR). The
safety profile of fruquintinib in FRUTIGA was consistent with
previously reported studies. Full detailed results are expected to
be disclosed at an upcoming scientific meeting.
HUTCHMED is also developing fruquintinib for the treatment of
multiple solid tumor cancers in combination with PD-1 monoclonal
antibodies for the treatment of endometrial and other solid
tumors.
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 approximately 5,000 personnel across
all its companies, at the center of which is a team of about 1,800
in oncology/ immunology. Since inception it has focused on bringing
cancer drug candidates from in-house discovery to patients 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.
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
https://www.takeda.com.
HUTCHMED CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490
Media Enquiries
Americas - Brad Miles, Solebury Strategic Communications +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 / Daphne Zhang, Panmure
Gordon +44 (20) 7886 2500
Takeda Media Contacts:
Japanese Media
Jun Saito
Jun.Saito@takeda.com
U.S. and International Media
Sara Noonan
Sara.Noonan@takeda.com
+1 (508) 566-2408
Emma Nash
Emma.Nash@takeda.com
+1 (404) 927-9113
HUTCHMED 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 submission of a
New Drug Application ("NDA") for fruquintinib for the treatment of
CRC with the FDA and the timing of such submission, the therapeutic
potential of fruquintinib for the treatment of patients with 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 CRC or
other indications in the U.S. or other jurisdictions such as Europe
or Japan, its potential to gain approvals from regulatory
authorities on an expedited basis or at all; the efficacy and
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; each party's ability to satisfy the terms and conditions
under the license agreement; actions of regulatory agencies, which
may affect the initiation, timing and progress of clinical trials
or the regulatory pathway for fruquintinib; Takeda's ability to
successfully develop and commercialize fruquintinib; 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 as combination
therapeutics with fruquintinib, such risks and uncertainties
include assumptions regarding the safety, efficacy, supply and
continued regulatory approval of these therapeutics. Such
forward-looking statements include, without limitation, statements
regarding the plan to develop and commercialize fruquintinib under
the license agreement; potential payments under the license
agreement, including the upfront payment and any milestone or
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HUTCHMED's strategy, goals and anticipated milestones, business
plans and focus. 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.
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Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to
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whether as a result of new information, future events or
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[1] Sung H, 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):209-249.
DOI:10.3322/caac.21660.
[2] Siegel RL, et al. Colorectal cancer statistics, 2023
[published online ahead of print, 2023 Mar 1]. CA Cancer J Clin .
2023;73(3):233-254. DOI:10.3322/caac.21772.
[3] Bando H, et al. Therapeutic landscape and future direction
of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol.
2023;20(5):306-322. DOI:10.1038/s41575-022-00736-1.
[4] D'Haene N, et al. Clinical application of targeted
next-generation sequencing for colorectal cancer patients: a
multicentric Belgian experience. Oncotarget.
2018;9(29):20761-20768. Published 2018 Apr 17.
DOI:10.18632/oncotarget.25099.
[5] Venderbosch, et al. Mismatch repair status and braf mutation
status in metastatic colorectal cancer patients: A pooled analysis
of the CAIRO, CAIRO2, COIN, and FOCUS Studies. Clinical Cancer
Res.2014;20(20), 5322-5330. DOI:10.1158/1078-0432.ccr-14-0332.
[6] Koopman, M., et al. Deficient mismatch repair system in
patients with sporadic advanced colorectal cancer. Br J Cancer,
2009;100(2), 266-273. DOI:10.1038/sj.bjc.6604867.
[7] Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The
Long and Winding Road From Negative Predictive Factor to Positive
Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14.
DOI:10.1200/EDBK_351354.
[8] Li J, 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.
[9] Dasari NA, et al. LBA25 - FRESCO-2: A global phase III
multiregional clinical trial (MRCT) evaluating the efficacy and
safety of fruquintinib in patients with refractory metastatic
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DOI:10.1016/annonc/annonc1089.
[10] Dasari NA, et al. Fruquintinib versus placebo in patients
with refractory metastatic colorectal cancer (FRESCO-2): an
international, multicentre, randomised, double-blind, phase 3 study
[published online ahead of print, 2023 Jun 15]. Lancet. 2023. DOI:
10.1016/S0140-6736(23)00772-9.
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