TIDMHCM
Hutchmed (China) Limited
19 December 2022
Press Release
HUTCHMED Initiates Rolling Submission of NDA to U.S. FDA for
Fruquintinib for the Treatment of Refractory Colorectal Cancer
- Company plans to complete rolling submission to the U.S. in
the first half of 2023, followed by filings in Europe and Japan
-
- NDA is supported by global Phase III FRESCO-2 study conducted
in the U.S., Europe, Japan and Australia -
- FRESCO-2 showed fruquintinib treatment reduced the risk of
death by 34% in metastatic colorectal cancer (0.66 HR) -
Hong Kong, Shanghai & Florham Park, NJ - Monday, December
19, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM,
HKEX:13) today announces that it has initiated the filing of a
rolling submission of a New Drug Application ("NDA") to the U.S.
Food and Drug Administration ("FDA") for fruquintinib, a highly
selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the
treatment of refractory metastatic colorectal cancer ("CRC").
HUTCHMED plans to complete the NDA submission in the first half of
2023, to be followed by 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").
The U.S. FDA granted Fast Track Designation for the development
of fruquintinib for the treatment of patients with metastatic CRC
in June 2020, enabling the company to submit sections of the NDA on
a rolling basis. The NDA is supported by the global Phase III
multi-regional clinical trial (MRCT) FRESCO-2 study conducted in
the U.S., Europe, Japan and Australia that investigated
fruquintinib plus best supportive care ("BSC") vs placebo plus BSC
in patients with refractory metastatic CRC.
The FRESCO-2 results were recently presented at the European
Society for Medical Oncology Congress 2022. The study demonstrated
that treatment with fruquintinib resulted in a statistically
significant and clinically meaningful increase in the primary
endpoint of overall survival ("OS") and the key secondary endpoint
of progression free survival ("PFS") 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). The 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. The safety profile of fruquintinib in FRESCO-2 was
consistent with previously reported fruquintinib studies. Treatment
related adverse events leading to discontinuation occurred in 20.4%
of patients who received fruquintinib, compared to 21.1% of
patients who received placebo.
"We are dedicated to executing on the next strategic steps in
bringing fruquintinib to patients outside of China, " said Dr.
Weiguo Su, Executive Director, Chief Executive Officer and Chief
Scientific Officer of HUTCHMED. "Colorectal cancer is one of the
most common cancers worldwide, and over 50,000 people in the U.S.
are estimated to die of colorectal cancer each year. Our U.S. NDA
submission includes the successful multi-regional clinical trial,
FRESCO-2, designed in consultation with the FDA, the EMA and the
PMDA. The study showed a meaningful survival benefit and anti-tumor
effect in patients treated with fruquintinib across patient
populations, consistent with the pivotal Phase III FRESCO study
supporting approval of fruquintinib for CRC in China. We look
forward to submitting additional new drug applications in Europe
and Japan next year."
Fruquintinib is approved in China under the brand name
ELUNATE(R) 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). It has been
included in the China National Reimbursement Drug List ("NRDL")
since January 2020. Approval in China is supported by the results
of the FRESCO study, a Phase III pivotal trial of fruquintinib in
416 patients with metastatic CRC in China.
HUTCHMED retains all commercial rights to fruquintinib outside
of China. In China, ELUNATE(R) is partnered with Eli Lilly and
Company.
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
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 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 (NCT02314819).
About Other Fruquintinib Developments
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 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 GEJ
adenocarcinoma (NCT03223376). Topline results were reported 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 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 NMPA.
HUTCHMED is also developing fruquintinib for the treatment of
multiple solid tumor cancers in combination with immunotherapies.
Fruquintinib is being evaluated in combination with PD-1 monoclonal
antibodies including tislelizumab (developed by BeiGene, Ltd) and
sintilimab (developed by Innovent Biologics, Inc.) for the
treatment of metastatic breast, endometrial and CRC in the U.S.
(NCT04577963); gastric, CRC and NSCLC in China and Korea (initiated
by BeiGene) (NCT04716634); and endometrial and other solid tumors
in China (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 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 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 submission of an
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 the E.U. or
Japan, 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 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] The Global Cancer Observatory. Accessed December 12,
2022.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/colorect.html.
Accessed December 12, 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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