RCS - Hutchmed China Ltd - HUTCHMED Presents Data at ESMO Immuno-Oncology ‘21

HUTCHMED (China)Announcement

10/12/2021 10:00

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RNS Number : 2686V  Hutchmed (China) Limited  10 December 2021

Press Release

 

HUTCHMED Highlights Surufatinib and Toripalimab Combination Clinical Data being Presented at the ESMO Immuno-Oncology 2021 Meeting

 

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, December 10, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that new analyses and updates on the
ongoing studies of surufatinib combined with toripalimab, in multiple disease
settings, presented at the European Society for Medical Oncology's (ESMO)
Immuno-Oncology Congress 2021, taking place virtually on December 8-11, 2021.
 

 

Further details of the poster presentations are as follows:

 

 Title:                    Surufatinib plus toripalimab in patients with advanced small cell lung cancer
                           (SCLC) after failure of 1L systemic chemotherapy
 First Author:             Ying Cheng, MD, Jilin Cancer Hospital
 Abstract No. & Link:      157P
                           (https://oncologypro.esmo.org/meeting-resources/esmo-immuno-oncology-congress-2021/surufatinib-plus-toripalimab-in-patients-with-advanced-small-cell-lung-cancer-sclc-after-failure-of-1l-systemic-chemotherapy)
 Date & Time:              Thursday, December 9, 2021, 11:30am - 11:50am CET

 Title:                    Surufatinib plus toripalimab for 2L treatment of advanced gastric or
                           gastro-esophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cell
                           carcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-arm
                           phase II study
 First Author:             Ming Lu, MD, Peking University Cancer Hospital & Institute
 Abstract No. & Link:      155P
                           (https://oncologypro.esmo.org/meeting-resources/esmo-immuno-oncology-congress-2021/surufatinib-plus-toripalimab-for-2l-treatment-of-advanced-gastric-or-gastroesophageal-junction-g-gej-adenocarcinoma-esophageal-squamous-cell-car)
 Date & Time:              Thursday, December 9, 2021, 10:50am - 11:10am CET

 

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

Extra-pancreatic Neuroendocrine Tumors ("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 1 . 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%).

 

Pancreatic Neuroendocrine Tumors ("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 2 , 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 toripalimab
(https://www.hutch-med.com/chi-med-initiates-a-phase-ii-trial-of-surufatinib-in-combination-with-tuoyi-in-patients-with-advanced-solid-tumors/)
, tislelizumab
(https://www.hutch-med.com/chi-med-and-beigene-collaboration-to-evaluate-surufatinib-and-fruquintinib-with-tislelizumab-combinations/)
and sintilimab
(https://www.hutch-med.com/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors/)
, which are approved as mono-therapies in China.

 

NETs in the U.S. and Europe: A U.S. Food and Drug Administration ("FDA") New
Drug Application (NDA) submission was accepted in June 2021
(https://www.hutch-med.com/fda-accepts-surufatinib-nda-for-net/) , followed by
a Marketing Authorisation Application (MAA) submission to the European
Medicines Agency (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 Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi
Biosciences. More than thirty company-sponsored toripalimab clinical studies
covering more than fifteen indications have been conducted globally, including
in China, the United States, Southeast Asia, and European countries. Ongoing
or completed pivotal clinical trials evaluating the safety and efficacy of
toripalimab cover a broad range of tumor types including cancers of the lung,
nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

 

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody
approved for marketing (approved in China as TUOYI(®)). To date, four
indications of toripalimab has been approved by the NMPA for the treatment of
melanoma, nasopharyngeal carcinoma ("NPC") and urothelial carcinoma. In the
United States, the FDA has granted priority review for the toripalimab
Biologics License Application (BLA) for the treatment of NPC, which currently
has no FDA-approved immuno-oncology treatment options. Earlier, the FDA
granted 2 Breakthrough Therapy designations, 1 Fast Track designation, 4
Orphan Drug designations for toripalimab.

 

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 4,500
personnel across all its companies, at the center of which is a team of over
1,400 in oncology/immunology. Since inception it has advanced eleven 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
therapeutic potential of surufatinib for patients, its expectations as to
whether any studies on surufatinib would meet their primary or secondary
endpoints, and its expectations as to the timing of the completion and the
release of results from such studies. Forward-looking statements involve risks
and uncertainties. Such risks and uncertainties include, among other things,
assumptions regarding enrollment rates and the timing and availability of
subjects meeting a study's inclusion and exclusion criteria; changes to
clinical protocols or regulatory requirements; unexpected adverse events or
safety issues; the ability of surufatinib, including as a combination therapy,
to meet the primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdictions and to gain commercial acceptance after
obtaining regulatory approval; the potential market of surufatinib for a
targeted indication; the sufficiency of funding; 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 toripalimab, tislelizumab or
sintilimab as combination therapeutics, such risks and uncertainties include
assumptions regarding their safety, efficacy, supply and continued regulatory
approval. 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.

 

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    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. Lancet Oncol. 2020;21(11):1500-1512. doi:
10.1016/S1470-2045(20)30496-4 (https://doi.org/10.1016/S1470-2045(20)30496-4)
.

 2    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. Lancet Oncol. 2020; 21(11):1489-1499. doi:
10.1016/S1470-2045(20)30493-9 (https://doi.org/10.1016/S1470-2045(20)30493-9)
.

 

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