RCS - Hutchmed China Ltd - HUTCHMED Highlights Presentations at CSCO 2021

HUTCHMED (China)Announcement

29/09/2021 07:00

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RNS Number : 2447N  Hutchmed (China) Limited  29 September 2021

Press Release

 

HUTCHMED Highlights Oral Presentations at 2021 Chinese Society of Clinical Oncology Annual Meeting

 

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, September 29, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM, HKEX: 13) announces that new and updated clinical data from
several ongoing combination studies of surufatinib (SULANDA(®) in China) or
fruquintinib (ELUNATE(®) in China) with PD-1 inhibitors were presented at the
24(th) Chinese Society of Clinical Oncology (CSCO) Annual Meeting which has
been taking place on September 25-29, 2021.

 

SURUFATINIB

 

 Title:           A phase II study of surufatinib in combination with toripalimab in patients
                  with advanced neuroendocrine carcinoma: an updated analysis
 Lead Author      Lin Shen, MD, Peking University Cancer Hospital & Institute
 Type:            Oral presentation
 Session Number:  CSCO Innovation Presentation 1-Session 2-#13
                  (http://reg2021.csco.org.cn/home/program/21)

 

Patients with advanced neuroendocrine carcinoma ("NEC") have a poor prognosis
and limited treatment options after first-line treatment. 5-year survival
rates are low. 1  Surufatinib is approved for the treatment of patients with
advanced or metastatic pancreatic and extra-pancreatic neuroendocrine tumors
in China. Toripalimab is a monoclonal humanized IgG4 PD-1 antibody that
previously demonstrated antitumor activity and safety in treating recurrent or
metastatic neuroendocrine neoplasms ("NENs"). 2  Results from a Phase II study
of the combination of surufatinib with toripalimab was first presented at the
2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021
(https://meetinglibrary.asco.org/record/199904/abstract) ). 3 

 

In this updated analysis, at later data cutoff date of July 30, 2021, all 21
enrolled patients were efficacy evaluable, with average duration of treatment
of 4.9 months (range 1-19). Median overall survival ("OS"), reported for the
first time, was 10.3 months (95% CI: 9.1-not reached). The median
progression-free survival ("PFS") was 4.14 months (95% CI: 1.5-5.5) and median
duration of response ("DoR") was 4.1 months (95% CI: 3.0-not reached). The
confirmed objective response rate ("ORR") was 23.8% (95% CI: 8.2-47.2) and
disease control rate ("DCR") was 71.4% (95% CI: 47.8-88.7).

 

All patients experienced treatment-related adverse events ("TRAEs"), including
9 (42.9%) who experienced grade 3 or above TRAEs. 1 (4.8%) patient reported
treatment-related serious adverse events ("SAEs"). Hyperglycemia (3  14.3% ),
hypertension (2  9.5% ) and hypertriglyceridemia (2  9.5% ) were the most
commonly (more than one patient) reported grade 3 or above TRAEs. There were
no TRAEs that led to treatment discontinuation or treatment-related deaths.

 

This updated analysis demonstrated the rationale of surufatinib plus
toripalimab in the second-line setting for the treatment of patients with
advanced NEC. A randomized phase III study SURTORI-01
(https://clinicaltrials.gov/ct2/show/NCT05015621) has been initiated to
further confirm the efficacy and safety of this combination therapy.

 

FRUQUINTINIB

 

 Title:           Fruquintinib plus sintilimab in patients with advanced endometrial cancer: a
                  multicentre, open-label, single-arm, phase II clinical trial
 Lead Author      Xiaohua Wu, MD, Fudan University Shanghai Cancer Center
 Type:            Oral presentation
 Session Number:  CSCO Innovation Presentation 2-Session 2-#9
                  (http://reg2021.csco.org.cn/home/program/21)

 

Platinum-based systemic chemotherapy is the standard first-line treatment for
advanced endometrial cancer ("EMC"). However, patients who progress following
first-line chemotherapy have limited treatment options, and the prognosis
remains poor. Therefore, an important unmet medical need remains in patients
with advanced EMC. Chemotherapy ORR is approximately 16%, while
anti-angiogenesis inhibitors and/or immune checkpoint inhibitors have
demonstrated less than a 15% ORR, with the exception of EMC patients with high
microsatellite instability or mismatch repair defects (about 16% of EMC
patients). 4  Fruquintinib is a highly selective vascular endothelial growth
factor receptor ("VEGFR") inhibitor and sintilimab is an anti-PD-1 monoclonal
antibody. This Phase II study aims to assess the efficacy and safety of
fruquintinib in combination with sintilimab for advanced EMC.

 

As of data cutoff date of August 31, 2021, 35 patients were enrolled,
including 7 treatment-naïve and 28 pretreated patients. Of them, 29 were
efficacy evaluable, 4 were treatment-naïve and 25 were pretreated. All 4
treatment-naïve patients experienced confirmed tumor response, for ORR of
100% (95% CI: 39.8-100.0), and median PFS was not reached. Among the 25
pretreated patients, the confirmed ORR was 32.0% (95% CI: 14.9-53.5), DCR was
92.0% (95% CI: 74.0-99.0) and the median PFS was 6.9 months (95% CI: 4.1-NR).
Among the 19 proficient mismatch repair (pMMR) patients in pretreated cohort,
the confirmed ORR was 36.8% (95% CI: 16.3-61.6), DCR was 94.7% (95% CI:
74.0-99.9), median PFS was 6.9 months (95% CI: 4.1-NR), and the median OS was
not reached.

 

Among the 35 enrolled patients, 33 (94.3%) patients experienced TRAEs,
including 17 (48.6%) who experienced grade 3 or above TRAEs. TRAEs of grade 3
or above that occurred in more than 10% of patients were hypertension (4
 11.4% ) and proteinuria (4  11.4% ). 5 (14.3%) patients reported
treatment-related SAEs. 2 patients experienced TRAEs that led to
discontinuation of sintilimab while 1 patient each discontinued fruquinintinb
alone or the fruquintinib and sintilimab combination.

 

Regulatory discussions for this combination in China are currently under
discussions with regulators, which may lead to the initiation of a pivotal
study before year end.

 

 

 Title:           A phase II study of fruquintinib plus sintilimab in pretreated patients with
                  advanced hepatocellular carcinoma
 Lead Author      Shukui Qin, MD, Eastern Theater General Hospital, Qinhuai Medical Area
 Type:            Oral presentation
 Session Number:  CSCO Innovation Presentation 2-Session 1-#7
                  (http://reg2021.csco.org.cn/home/program/21)

 

Patients with hepatocellular carcinoma ("HCC"), the most common type of liver
cancer, have very limited treatment options. Combination use of VEGF targeting
therapy with immunotherapy has demonstrated remarkable clinical benefits in
first-line HCC, but its anti-tumor activity in second- or later line
treatments is not established. This phase II study was performed to assess the
combination of fruquintinib, a highly selective VEGFR inhibitor, with
sintilimab, an anti-PD-1 antibody, in patients with advanced HCC who were
treated with at least one prior line of treatment, including either sorafenib
or lenvatinib. The combination demonstrated preliminary anti-tumor efficacy
and durability in these patients.

 

As of data cutoff date of August 31, 2021, among 19 response-evaluable
patients, the confirmed ORR was 31.6% (95% CI: 12.6-56.6), and the DCR was
89.5% (95% CI: 66.9-98.7). The median DoR was not reached. The median PFS was
6.9 months (95% CI: 4.1-not reached). With a median follow up of 7.4 months,
the median OS was not reached.

 

Among 21 enrolled patients, 20 (95.2%) patients experienced TRAEs, including 7
(33.3%) who experienced grade 3 or above TRAEs. No TRAEs of grade 3 or above
occurred in more than one patient. 4 (19.0%) patients reported
treatment-related SAEs. TRAEs leading to fruquintinib discontinuation and
sintilimab discontinuation were reported in 2 (9.5%) and 1 (4.8%) patient,
respectively.

 

Registration plans for this combination regimen in China are currently under
discussions with investigators.

 

 

 Title:           Fruquintinib plus sintilimab in patients with advanced renal cell carcinoma:
                  results from a phase II clinical trial
 Lead Author      Dingwei Ye, MD, Fudan University Shanghai Cancer Center
 Type:            Oral presentation
 Session Number:  CSCO Innovation Presentation 2-Session 2-#13
                  (http://reg2021.csco.org.cn/home/program/21)

 

In first-line clear-cell renal cell carcinoma ("ccRCC"), clinical benefits
have been demonstrated for the combination of antiangiogenic therapy and
immunotherapy. However, there is limited evidence on the benefits of this
combination in the second-line setting. This phase II study aimed to evaluate
the efficacy and safety of fruquintinib plus sintilimab in second-line
treatment of ccRCC, which has shown encouraging anti-tumor efficacy and
durability in these patients.

 

As of data cutoff date of August 31, 2021, all 20 enrolled patients were
efficacy evaluable. 19 patients previously received VEGFR inhibitors, and 2
received interferon. The confirmed ORR was 55.0% (95% CI: 31.5-76.9) and DCR
was 85.0% (95% CI: 62.1-96.8).  The median PFS was not reached with a median
follow up of 8.2 months. PFS rate at 9 months was 63.6% (95% CI: 38.1-80.9).
Median treatment time was 38.6 weeks, with the longest being over 50 weeks and
ongoing.

 

All patients experienced TRAEs, including 9 (45%) who experienced grade 3 or
above TRAEs. The most common (more than one patient) grade 3 or above TRAEs
were increased amylase (3  15.0% ), hypertriglyceridemia (3  15.0% ),
hypertension (2  10.0% ) and lipase increased (2  10.0% ). Treatment-related
SAEs were reported in 2 patients (10.0%). There were no TRAEs that led to
treatment discontinuation.

 

Registration plans for this combination regimen in China are currently under
discussions with investigators.

 

About Surufatinib (SULANDA(®) in China)

 

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively
inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which
both inhibit angiogenesis, and 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 Fruquintinib (ELUNATE(®) in China)

 

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -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.

 

HUTCHMED retains all rights to fruquintinib outside of China. In China,
HUTCHMED is partnered with Eli Lilly and Company and is responsible for
development and execution of all on-the-ground medical detailing, promotion
and local and regional marketing.

 

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. 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 and marketed. For more
information, please visit: www.hutch-med.com (http://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 can be identified by words like
"will," "expects," "anticipates," "future," "intends," "plans," "believes,"
"estimates," "pipeline," "could," "potential," "first-in-class," "designed
to," "objective," "guidance," "pursue," or similar terms, or by express or
implied discussions regarding potential drug candidates, potential indications
for drug candidates or by discussions of strategy, plans, expectations or
intentions. You should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and expectations
of management regarding future events, and are subject to significant known
and unknown risks and uncertainties. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the forward-looking
statements. There can be no guarantee that any of our drug candidates will be
approved for sale in any market, or that any approvals which are obtained will
be obtained at any particular time, or that any such drug candidates will
achieve any particular revenue or net income levels. In particular,
management's expectations could be affected by, among other things: unexpected
regulatory actions or delays or government regulation generally; the
uncertainties inherent in research and development, including the inability to
meet our key study assumptions regarding enrollment rates, timing and
availability of subjects meeting a study's inclusion and exclusion criteria
and funding requirements, changes to clinical protocols, unexpected adverse
events or safety, quality or manufacturing issues; the inability of a drug
candidate to meet the primary or secondary endpoint of a study; the inability
of a drug candidate to obtain regulatory approval in different jurisdictions
or gain commercial acceptance after obtaining regulatory approval; global
trends toward health care cost containment, including ongoing pricing
pressures; uncertainties regarding actual or potential legal proceedings,
including, among others, actual or potential product liability litigation,
litigation and investigations regarding sales and marketing practices,
intellectual property disputes, and government investigations generally; the
impact of the COVID-19 pandemic or other health crises in China or globally on
general economic, regulatory and political conditions; and general economic
and industry conditions, including uncertainties regarding the effects of the
persistently weak economic and financial environment in many countries and
uncertainties regarding future global exchange rates. 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 is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking statements
as a result of new information, future events 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    Dasari A, Mehta K, Byers LA, Sorbye H, Yao JC. Comparative study of
lung and extrapulmonary poorly differentiated neuroendocrine carcinomas: A
SEER database analysis of 162,983 cases. Cancer. 2018;124(4):807-815.
doi:10.1002/cncr.31124.

 2    Lu M, Zhang P, Zhang Y, et al. Efficacy, Safety, and Biomarkers of
Toripalimab in Patients with Recurrent or Metastatic Neuroendocrine Neoplasms:
A Multiple-Center Phase Ib Trial. Clin Cancer Res. 2020;26(10):2337-2345.
doi:10.1158/1078-0432.CCR-19-4000
(https://doi.org/10.1158/1078-0432.ccr-19-4000) .

 3    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. 2021
39:15_suppl, e16199-e16199. doi: 10.1200/JCO.2021.39.15_suppl.e16199n.

 4    2019 ESMO, Discussant abstracts LBA62 and 994O; Le et al. NEJM. 2015;
372; 2509 -20; Ott et al. J Clin Oncol. 2017; 35(22): 2535; Fleming et al. J
Clin Oncol 35, 2017 (suppl; abstr 5585); Hasegawa et al. J Clin Oncol (36,
2018 (suppl: abstr 5594), Le Science 2017; Oaknin, SGO 2019; 5594);
Konstantinopoulos ASCO 2019.

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