RCS - Hutchmed China Ltd - FDA NDA Rolling Submission for Fruquintinib

HUTCHMED (China)Announcement

19/12/2022 10:00

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RNS Number : 1462K  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 (https://www.hutch-med.com/) ")
(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
(https://www.hutch-med.com/fruquintinib-fresco-2-data-summary-esmo-2022/) 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(®) 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(®) 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(®). It has
been included in the NRDL since January 2020. ELUNATE(®) 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
(https://jamanetwork.com/journals/jama/fullarticle/2685988) in The Journal of
the American Medical Association, JAMA, in June 2018 (NCT02314819
(https://clinicaltrials.gov/ct2/show/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
(https://clinicaltrials.gov/ct2/show/record/NCT03223376) ). Topline results
were reported
(https://www.hutch-med.com/fruquintinib-frutiga-gastric-cancer-topline-result/)
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 (https://clinicaltrials.gov/ct2/show/NCT04577963) );
gastric, CRC and NSCLC in China and Korea (initiated by BeiGene) (NCT04716634
(https://clinicaltrials.gov/ct2/show/NCT04716634) ); and endometrial and other
solid tumors in China (NCT03903705
(https://clinicaltrials.gov/ct2/show/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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/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 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 (mailto:bmiles@soleburystrat.com)
                                                   oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                   (mailto:bmiles@soleburystrat.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
                                                   (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                         +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                   (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley, Panmure Gordon  +44 (20) 7886 2500

 

 1  The Global Cancer Observatory (https://gco.iarc.fr/) . Accessed December
12, 2022.

 2  SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer Institute.
https://seer.cancer.gov/statfacts/html/colorect.html
(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 (https://doi.org/10.1001/jama.2018.7855) .

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