TIDMHCM
Hutchmed (China) Limited
27 October 2022
Press Release
HUTCHMED Initiates a Phase II/III Trial of Fruquintinib in
Combination with Sintilimab for Advanced Renal Cell Carcinoma in
China
Hong Kong, Shanghai & Florham Park, NJ - Thursday, October
27, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated a Phase II/III trial
of fruquintinib in combination with sintilimab as second-line
treatment for locally advanced or metastatic renal cell carcinoma
("RCC") in China. The first patient in China received the first
dose on October 27, 2022.
The study is a randomized, open-label, active-controlled study
to evaluate the efficacy and safety of fruquintinib in combination
with sintilimab versus axitinib or everolimus monotherapy for the
second-line treatment of advanced RCC. The primary endpoint is
progression free survival ("PFS") per RECIST 1.1 as assessed by
blinded independent central review (BICR). The secondary endpoints
include safety, quality of life, disease control rate ("DCR"),
duration of response, time to response and overall survival ("OS").
Approximately 260 patients will be enrolled in the study. The
leading principal investigators are Dr Dingwei Ye of Fudan
University Shanghai Cancer Center and Dr Zhisong He of Peking
University First Hospital. Additional details may be found at
clinicaltrials.gov, using identifier NCT05522231.
About Kidney Cancer and RCC
It is estimated that approximately 430,000 new patients were
diagnosed with kidney cancer worldwide in 2020. [1] In China, an
estimated 74,000 new patients were diagnosed with kidney cancer in
2020. [2] Approximately 90% of kidney tumors are RCC.
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 Fruquintinib and Second-line treatment of RCC
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.
The U.S. Food and Drug Administration ("FDA") has approved five
immune-oncology combination therapies for first-line treatment of
advanced RCC, however, no immune-oncology combination therapies
have been approved in China, indicating an unmet medical need in
these settings. As presented at the 2021 Chinese Society of
Clinical Oncology Annual Meeting (CSCO), a Phase Ib/II study of
fruquintinib in combination with sintilimab for the second-line
treatment of RCC demonstrated promising efficacy and tolerable
safety profile in this setting.
As of the data cutoff date of August 31, 2021, all 20 enrolled
patients in such Phase Ib/II study were efficacy evaluable. 19
patients previously received VEGFR inhibitors, and one received
interferon. The confirmed objective response rate (ORR) was 55.0%
(95% CI: 31.5-76.9) and DCR was 85.0% (95% CI: 62.1-96.8). PFS rate
at 9 months was 63.6% (95% CI: 38.1-80.9). Both median PFS and OS
were not reached. Median treatment time was 38.6 weeks, with the
longest being over 50 weeks and ongoing.
About Fruquintinib Development In CRC Monotherapy
Metastatic colorectal cancers ("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). 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).
Metastatic CRC outside China: 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.
About Other Fruquintinib Development
Gastric Cancer 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 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 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 RCC 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
RCC, CRC, gastric cancer, TNBC, endometrial cancer 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, kidney cancer fact sheet. https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf. Accessed September 28, 2022.
[2] The Global Cancer Observatory, China fact sheet.
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
. Accessed September 30, 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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