RCS - Hutchmed China Ltd - HUTCHMED Initiates Phase II/III Trial with Hengrui

HUTCHMED (China)Announcement

14/05/2024 07:00

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RNS Number : 2027O  Hutchmed (China) Limited  14 May 2024

Press Release

 

HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui

 

- Almost half a million people diagnosed each year across the globe -

 

- Collaboration based on synergistic potential of inhibiting angiogenesis and
tumor-associated macrophages with HUTCHMED's surufatinib and anti-PD-1
activity with Hengrui's camrelizumab, promoting the immune response against
tumor cells -

 

Hong Kong, Shanghai & Florham Park, NJ -  Tuesday, May 14, 2024: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces the initiation of a Phase II/III trial to evaluate
the efficacy of a combination of the HUTCHMED drug candidate surufatinib, the
Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui Pharma") PD-1 antibody
camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for
patients with metastatic pancreatic ductal adenocarcinoma ("PDAC") in China.
PDAC is an exocrine tumor and the most common form of pancreatic cancer. The
first patient received the first dose on May 8, 2024.

 

PDAC is a highly aggressive form of cancer, representing over 90% of
pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed
with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with
an average five-year survival rate of less than 10%. In China, an estimated
119,000 people were diagnosed with pancreatic cancer, causing approximately
106,000 deaths in 2022. 1  (#_edn1) Treatments such as chemotherapy, surgery
and radiation are commonly employed, but have not shown significant
improvement in patient outcomes. Under 20% of metastatic pancreatic cancer
patients survive more than a year. 2  (#_edn2)

 

The trial is a multicenter, randomized, open-label, active-controlled, Phase
II/III trial to evaluate the efficacy and safety of surufatinib combined with
camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus
gemcitabine as a treatment for adults with metastatic pancreatic cancer who
have not been previously treated with a systemic anti-tumor therapy. After an
initial safety run-in stage, the Phase II/III stage of the study may enroll a
further 500 patients, with a primary endpoint of overall survival (OS). Other
endpoints include objective response rate (ORR), progression free survival
(PFS), disease control rate (DCR), safety, quality of life, duration of
response and time to response. Additional details may be found at
clinicaltrials.gov, using identifier NCT06361888
(https://clinicaltrials.gov/study/NCT06361888) .

 

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of
HUTCHMED, said, "Emerging data including those from an investigator-initiated
study presented at the ASCO Gastrointestinal Cancers Symposium, demonstrated
that combinations of surufatinib, camrelizumab and chemotherapy have promising
efficacy in comparison with existing chemotherapy-based treatments in
metastatic PDAC. 3  (#_edn3) We hope that this partnership will enable us to
bring new, potentially life-changing treatment options to patients."

 

About Surufatinib

 

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively
inhibits the tyrosine kinase activity associated with vascular endothelial
growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR),
which both inhibit angiogenesis, and colony stimulating factor-1 receptor
(CSF-1R), which regulates tumor-associated macrophages, promoting the body's
immune response against tumor cells. Its unique dual mechanism of action may
be very suitable for possible combinations with other immunotherapies, where
there may be synergistic anti-tumor effects.

 

Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA(®),
and was first included in the China National Reimbursement Drug List (NRDL) in
January 2022 for the treatment of non-pancreatic and pancreatic neuroendocrine
tumors (NETs).

 

About Camrelizumab

 

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the
programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling
pathway is a therapeutic strategy showing success in a wide variety of solid
and hematological cancers. Currently, more than 10 clinical trials are
underway worldwide in a broad range of tumors  and treatment settings.

 

Camrelizumab, under the brand name AiRuiKa(®), is currently approved for nine
indications in China, including hepatocellular carcinoma ("HCC") (second-line
and first-line), relapsed/refractory classic Hodgkin's lymphoma (third-line),
esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma
(third-line or further) and in combination with chemotherapy for the treatment
of non-small cell lung cancer (non-squamous and squamous), esophageal squamous
cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. All
indications have been included in China's national medical insurance catalog,
making it the leading domestic PD-1 product in terms of approved indications
and tumor types covered. The U.S. Food and Drug Administration ("FDA") granted
Orphan Drug Designation to camrelizumab for advanced HCC in April 2021, and
accepted a New Drug Application (NDA) for camrelizumab and rivoceranib as a
first-line therapy for unresectable HCC, with FDA Prescription Drug User Fee
Act (PDUFA) dates in May 2024.

 

About Hengrui Pharma

 

Hengrui Pharma is a leading global pharmaceutical company headquartered in
China with a focus on research, development, manufacturing, and
commercialization of innovative and high-quality healthcare products.
Innovation is the core development strategy. Hengrui Pharma ranked 24(th)
among top 1,000 global pharmaceutical companies in 2021. Hengrui Pharma has
been on the Pharma Exec's annual listing of the top 50 global pharmaceutical
companies for the fifth consecutive year.

 

About HUTCHMED

 

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery, 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, HUTCHMED has focused on
bringing cancer drug candidates from in-house discovery to patients around the
world. Its first three medicines are marketed in China, the first of which is
also marketed in the U.S. 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
therapeutic potential of surufatinib for the treatment of patients with PDAC
and the further development of surufatinib 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 an NDA submission of surufatinib for the treatment of patients with
PDAC or other indications in China or other jurisdictions, its potential to
gain approvals from regulatory authorities on an expedited basis or at all,
the efficacy and safety profile of surufatinib, HUTCHMED's ability to fund,
implement and complete its further clinical development and commercialization
plans for surufatinib and the timing of these events. In addition, as certain
studies rely on the use of other drug products such as camrelizumab as
combination therapeutics with surufatinib, 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, The Stock Exchange of Hong Kong Limited and on AIM. 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.

 
Medical Information

 

This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.

 

CONTACTS
 Investor Enquiries                                                    +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 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)
 Zhou Yi, Brunswick                                                    +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                       (mailto:HUTCHMED@brunswickgroup.com)

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

 

 1  (#_ednref1)    The Global Cancer Observatory (https://gco.iarc.fr/)
, World Fact Sheets
(https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf)
. Accessed April 9, 2024.

 2  (#_ednref2)   Sarantis P et al. Pancreatic ductal adenocarcinoma:
Treatment hurdles, tumor microenvironment and immunotherapy. World J
Gastrointest Oncol. 2020;12(2):173-181. DOI:10.4251/wjgo.v12.i2.173
(https://doi.org/10.4251%2Fwjgo.v12.i2.173)

 3  (#_ednref3)   Jia R et al. Updated results of a phase 1b/2 study of
surufatinib plus camrelizumab, nab-paclitaxel and S-1 (NASCA) as first-line
therapy for metastatic pancreatic adenocarcinoma (mPDAC).
JCO 42, 671-671(2024). DOI:10.1200/JCO.2024.42.3_suppl.671
(https://doi.org/10.1200/JCO.2024.42.3_suppl.671)

 

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