RCS - Hutchmed China Ltd - HUTCHMED Initiates Phase III Trial SURTORI-01

HUTCHMED (China)Announcement

21/09/2021 07:00

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RNS Number : 3417M  Hutchmed (China) Limited  21 September 2021

Press Release

 

HUTCHMED Initiates SURTORI-01, a Phase III Trial of SULANDA(®) in Combination with TUOYI(®) in the Treatment of Advanced Neuroendocrine Carcinoma in China

 

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, September 21, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated SURTORI-01,
a Phase III study to evaluate the efficacy and safety of surufatinib
(SULANDA(®) in China) in combination with toripalimab compared with FOLFIRI
to treat patients with advanced neuroendocrine carcinoma ("NEC") who have
progression of disease or intolerable toxicity after previous first-line
chemotherapy. The first patient was dosed on September 18, 2021 in China.
Toripalimab is marketed as TUOYI(®) in China by Shanghai Junshi Biosciences
Co., Ltd. ("Junshi Biosciences").

 

Professor Shen Lin, the lead principal investigator of the study and Vice
President of Peking University Hospital and Cancer Institute, said: "There is
a large unmet clinical need for patients with NEC, many of whom have a bleak
prognosis. Following the encouraging preliminary data from the Phase II trial,
we are excited to move into the next stage of development in combining the
novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1
antibody toripalimab. We look forward to further testing the synergistic
anti-tumor effects of this combination that could benefit NEC patients who
have limited treatment options."

 

At the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting,
encouraging preliminary data from the Phase II trial were disclosed for the
surufatinib and toripalimab combination 1 . For the 20 patients in the NEC
cohort as of December 31, 2020, who received an average of 5 cycles of
treatments and are efficacy evaluable, objective response rate ("ORR") was 20%
and disease control rate ("DCR") was 70%. Median progression-free survival
("PFS") was 3.9 months (95% CI: 1.3 - not reached). Grade 3 or higher
treatment-related adverse events occurred in 33% of patients. Treatment
related adverse events ("TRAEs") were manageable, with surufatinib or
toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients
respectively. There were neither serious adverse events ("AEs") nor AEs
inducing treatment discontinuations or deaths. Updated data will be presented
at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting in late
September.

 

The SURTORI-01 Phase III study is a randomized, controlled, open-label,
multi-center study where approximately 200 patients are expected to be
enrolled. For the study group, all patients will receive study treatment in
21-day cycle and the treatment will continue until there is a progression of
disease, death, intolerable toxicity, or the end of study treatment (as other
criteria specified in the protocol are met), whichever occurs first. The
primary outcome measure is OS. The secondary outcome measures include PFS,
ORR, duration of response (DoR), and DCR. Additional details may be found at
clinicaltrials.gov, using identifier NCT05015621
(https://clinicaltrials.gov/ct2/show/NCT05015621) .

 

HUTCHMED is the sponsor of SURTORI-01 and responsible for all clinical and
regulatory execution of the Phase III study. HUTCHMED and Junshi Biosciences
are jointly funding the study.

 

Surufatinib is marketed in China under the brand name SULANDA(®) for treating
advanced neuroendocrine tumors ("NETs").

 

 

About NEC

 

Neuroendocrine neoplasms ("NEN") occur almost everywhere in the body but are
most common in the gastrointestinal tract, pancreas, and lungs. NEC is one of
the two common phenotypes of NEN. NECs are poorly differentiated, highly
proliferating NENs, while NETs are well-differentiated, low-proliferating
NENs. NECs are aggressive, fast-growing neoplasms that usually fail to express
hormones or produce hormonal syndromes, and are not associated with hereditary
tumor diseases. 2 

 

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 NETs ("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 3 . 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 NETs ("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 4 , 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 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 the first domestic anti-PD-1 monoclonal antibody to obtain
marketing approval in China. So far, more than thirty company-sponsored
clinical studies covering more than fifteen indications have been conducted
globally including in China and the United States. On December 17, 2018,
toripalimab was granted conditional approval from the NMPA for the second-line
treatment of patients with unresectable or metastatic melanoma. In December
2020, toripalimab was successfully included in the updated National
Reimbursement Drug List. In February 2021, toripalimab received NMPA's
conditional approval for the treatment of patients with recurrent or
metastatic nasopharyngeal carcinoma ("NPC") after failure of at least two
lines of prior systemic therapy. In April 2021, toripalimab received NMPA's
conditional approval for the treatment of patients with locally advanced or
metastatic urothelial carcinoma who failed platinum-containing chemotherapy or
progressed within 12 months of neoadjuvant or adjuvant platinum-containing
chemotherapy. In addition, toripalimab has been included in the Guidelines of
the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and
Treatment of Melanoma, Head and Neck Tumors, Urothelial Carcinoma and other
indications.

 

In February 2021, the supplemental new drug application (the "sNDA") of
toripalimab in combination with cisplatin and gemcitabine as the first-line
treatment for patients with locally recurrent or metastatic NPC was accepted
for review by the NMPA. In March 2021, toripalimab received Breakthrough
Therapy Designation for the first-line treatment of advanced mucosal melanoma
by the NMPA. In July 2021, the sNDA for toripalimab in combination with
platinum-containing chemotherapy as the first-line treatment for patients with
locally advanced or metastatic esophageal squamous cell carcinoma was accepted
for review by the NMPA.

 

In terms of international development, the first toripalimab Biological
License Application (BLA) has been submitted to the FDA for the treatment of
recurrent or metastatic NPC. The FDA has granted two Breakthrough Therapy
designations for toripalimab in combination with chemotherapy for the first
line treatment of recurrent or metastatic NPC and also for toripalimab
monotherapy in second or third line treatment of recurrent or metastatic NPC.
Additionally, FDA has granted Fast Track designation for toripalimab for the
treatment of mucosal melanoma and orphan drug designations for NPC, mucosal
melanoma and soft tissue sarcoma.

 

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 NEC
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 NEC in the U.S., China 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    Shen L, Yu X, Lu M, et al. Surufatinib in combination with toripalimab
in patients with advanced neuroendocrine carcinoma: Results from a
multicenter, open-label, single-arm, phase II trial. J Clin Oncol. 39, 2021
(suppl 15; abstr e16199). doi: 10.1200/JCO.2021.39.15_suppl.e16199
(https://doi.org/10.1200/JCO.2021.39.15_suppl.e16199) .

 2    Klöppel G. Neuroendocrine Neoplasms: Dichotomy, Origin and
Classifications. Visc Med. 2017 ;33(5):324-330. doi:10.1159/000481390
(https://doi.org/10.1159/000481390) .

 3    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)
.

 4    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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