RCS - Hutchmed China Ltd - Japan Bridging Study For Surufatinib Initiated

HUTCHMED (China)Announcement

20/09/2021 07:00

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RNS Number : 2215M  Hutchmed (China) Limited  20 September 2021

Press Release

 

HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors

 

- Following surufatinib launch in China in January 2021; NDA acceptance by the
U.S. FDA for review in June 2021; and MAA validation by the EMA in July 2021
all for advanced neuroendocrine tumors -

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, September 20, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan
registration-enabling bridging study for surufatinib to support the
registration of surufatinib in the treatment of patients with advanced
neuroendocrine tumors ("NETs").  The first patient was dosed on September 15,
2021.

 

Based on dialogue with the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA), it was agreed that the surufatinib Japanese new drug application
("NDA") for the treatment of advanced NETs include results from a pivotal
study to be conducted in Japan, to complement the registration data package
supporting the NDA to the U.S. Food and Drug Administration ("FDA") (accepted
for review in June 2021) and the Marketing Authorization Application ("MAA")
to the European Medicines Agency ("EMA") (validated in July 2021). The basis
for the NDA and the MAA includes data from a U.S. Phase I/II study, as well as
the completed Phase III SANET-ep and SANET-p studies used to support marketing
authorization in China in advanced NETs, where surufatinib is currently
marketed under the brand name SULANDA(®).

 

This Japan study is a two-stage, open label study of surufatinib where
approximately 34 patients are expected to be recruited. In Part 1 of the
study, the safety and tolerability of surufatinib 300mg once daily after 28
days of treatment will be assessed in patients with relapsed/refractory
non-hematological malignancies; pharmacokinetics ("PK") and anti-tumor
activity of surufatinib are secondary endpoints. In Part 2 of the study,
efficacy will be assessed in patients with locally advanced or metastatic
NETs; the primary outcome measure is objective response rate (ORR). The
secondary outcome measures include disease control rate (DCR), progression
free survival ("PFS"), duration of response (DoR), safety, and PK.

 

Surufatinib is the third potential new medicine discovered by HUTCHMED to
enter into clinical development in Japan. A global Phase III registration
study for fruquintinib, known as the FRESCO-2
(https://clinicaltrials.gov/ct2/show/NCT04322539) study, is ongoing in
patients with refractory metastatic colorectal cancer and is expected to
enroll over 680 patients from over 150 sites in 14 countries, including Japan.
A global single-arm, open-label study, known as the SAVANNAH
(https://clinicaltrials.gov/ct2/show/NCT03778229) study, is ongoing for
savolitinib (partnered with AstraZeneca PLC) in combination with TAGRISSO(®)
in non-small cell lung cancer patients whose disease progressed following
TAGRISSO(®) due to MET amplification or overexpression.

 

About NETs

 

NETs form in cells that interact with the nervous system or in glands that
produce hormones. They can originate in various parts of the body, most often
in the gut or the lungs and can be benign or malignant. NETs are typically
classified as pancreatic NET ("pNET") or extra-pancreatic (non-pancreatic) NET
("epNET").

 

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of
NET in the U.S. in 2020. Rates across the European Union (E.U.) appear largely
similar to the U.S. This is supported by an analysis of global epidemiologic
trends, which also show growth in the incidence of NETs worldwide. 1 
Importantly, NETs are associated with a relatively long duration of survival
compared to other tumors. As a result, there were approximately 140,000
estimated patients living with NET in France, Germany, Italy, Spain, and the
United Kingdom in 2020. 2  In Japan, approximately 6,700 people were diagnosed
with gastro-entero-pancreatic neuroendocrine neoplasms in 2016. 3 

 

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 (VEGFR) 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.

 

HUTCHMED currently retains all rights to surufatinib worldwide.

 

About Surufatinib Development

 

epNETs in China: On December 29, 2020, surufatinib was granted drug
registration approval
(https://www.hutch-med.com/chi-med-announces-the-nmpa-approval-of-surufatinib-sulanda-in-china-for-epnet/)
by the National Medical Products Administration of China ("NMPA") for the
treatment of epNET. Surufatinib is marketed in China under the brand name
SULANDA(®). The approval was based on results from the SANET-ep study, a
Phase III trial (clinicaltrials.gov identifier: NCT02588170
(https://clinicaltrials.gov/ct2/show/NCT02588170) ) in patients with advanced
epNETs conducted in China. The study met the pre-defined primary endpoint of
PFS at a preplanned interim analysis, and was published
(https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30496-4/fulltext)
in The Lancet Oncology 4 . Median PFS was significantly longer for patients
treated with surufatinib at 9.2 months, compared to 3.8 months for patients in
the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib
had an acceptable safety profile, with the most common treatment related
adverse events of grade 3 or worse being hypertension (36% of surufatinib
patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5%
vs. 3%).

 

pNETs in China: On June 16, 2021, surufatinib was granted drug registration
approval
(https://www.hutch-med.com/nmpa-approval-of-surufatinib-for-advanced-pnet/) by
the NMPA for the treatment of pNET. The approval was based on results from the
SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821
(https://clinicaltrials.gov/ct2/show/NCT02589821) ) in patients with advanced
pNET in China. The pre-defined primary endpoint of PFS was met
(https://www.hutch-med.com/surufatinib-phase-iii-sanet-p-study-achieved-primary-endpoint/)
at a preplanned interim analysis and was published
(https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30493-9/fulltext)
in The Lancet Oncology 5 , demonstrating that surufatinib reduces the risk of
disease progression or death by 51% in patients, with a median PFS of 10.9
months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755;
p=0.0011). The safety profile of surufatinib was manageable and consistent
with observations in prior studies.

 

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to
evaluate the safety, tolerability and efficacy of surufatinib in combination
with anti-PD-1 monoclonal antibodies, including with tislelizumab
(https://www.hutch-med.com/chi-med-and-beigene-collaboration-to-evaluate-surufatinib-and-fruquintinib-with-tislelizumab-combinations/)
(BGB-A317), TUOYI
(https://www.hutch-med.com/chi-med-initiates-a-phase-ii-trial-of-surufatinib-in-combination-with-tuoyi-in-patients-with-advanced-solid-tumors/)
(®
(https://www.hutch-med.com/chi-med-initiates-a-phase-ii-trial-of-surufatinib-in-combination-with-tuoyi-in-patients-with-advanced-solid-tumors/)
) (toripalimab) and TYVYT
(https://www.hutch-med.com/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors/)
(®
(https://www.hutch-med.com/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors/)
) (sintilimab), which are approved as monotherapies in China.

 

NETs in the U.S. and Europe: A FDA NDA submission was accepted in June 2021
(https://www.hutch-med.com/fda-accepts-surufatinib-nda-for-net/) , followed by
a MAA submission to the EMA validated in July 2021. The basis to support these
filings includes the completed SANET-ep and SANET-p studies, along with
existing data from surufatinib in U.S. epNET and pNET patients
(clinicaltrials.gov identifier: NCT02549937
(https://clinicaltrials.gov/ct2/show/NCT02549937) ). In the U.S., surufatinib
was granted Fast Track Designations
(https://www.hutch-med.com/surufatinib-granted-us-fda-fast-track-designations/)
for development in pNET and epNET in April 2020, and Orphan Drug Designation
(https://www.hutch-med.com/surufatinib-fda-orphan-drug-designation/) for pNET
in November 2019.

 

HUTCHMED has initiated an Expanded Access Protocol
(https://www.hutch-med.com/pipeline-and-products/expanded-access/) (EAP) in
the U.S. to ensure patients with NET with limited therapeutic options have
access to this treatment. Regulatory clearance of this protocol has been
granted by the FDA and this program is open for site activation
(clinicaltrials.gov identifier: NCT04814732
(https://clinicaltrials.gov/ct2/show/NCT04814732) ).

 

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. A dedicated
organization of over 1,400 personnel has advanced eleven cancer drug
candidates from in-house discovery into clinical studies around the world,
with its first three oncology drugs now approved. 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 NET
and the further clinical 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
sufficiency of clinical data to support NDA approval of surufatinib for the
treatment of patients with NET in the U.S., China, Japan and other
jurisdictions such as the E.U., its potential to gain expeditious approvals
from regulatory authorities, the safety profile of surufatinib, HUTCHMED's
ability to fund, implement and complete its further clinical development and
commercialization plans for surufatinib, 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 capecitabine,
tislelizumab, TUOYI(®), and TYVYT(®) 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, 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,             +1 (917) 570 7340 (Mobile)

Solebury Trout
bmiles@troutgroup.com (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                    +44 7779 545 055 (Mobile)

HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick

                                    HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

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

Panmure Gordon (UK) Limited

 

 

 1  Fraenkel M, Kim M, Faggiano A, de Herder WW, Valk GD; Knowledge NETwork.
Incidence of gastroenteropancreatic neuroendocrine tumours: a systematic
review of the literature. Endocr Relat Cancer. 2014;21(3):R153-R163. Published
2014 May 6. doi: 10.1530/ERC-13-0125 (https://doi.org/10.1530/erc-13-0125) .

 2  According to Frost & Sullivan, in 2020, there were 19,000 newly
diagnosed cases of NETs in the U.S. and an estimated 143,000 patients living
with NETs. Report on file.

 3  Masui T, Ito T, Komoto I, Uemoto S; JNETS Project Study Group. Recent
epidemiology of patients with gastro-entero-pancreatic neuroendocrine
neoplasms (GEP-NEN) in Japan: a population-based study. BMC Cancer.
2020;20(1):1104. Published 2020 Nov 14. doi: 10.1186/s12885-020-07581-y
(https://doi.org/10.1186/s12885-020-07581-y) .

 4  Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic
neuroendocrine tumours (SANET-ep): a randomised, double-blind,
placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep
20]. Lancet Oncol. 2020; S1470-2045(20)30496-4.
doi:10.1016/S1470-2045(20)30496-4
(https://doi.org/10.1016/S1470-2045(20)30496-4) .

 5  Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic
neuroendocrine tumours (SANET-p): a randomised, double-blind,
placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep
20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. doi:
10.1016/S1470-2045(20)30493-9 (https://doi.org/10.1016/S1470-2045(20)30493-9)
.

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