TIDMHCM
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")
(Nasdaq/AIM: HCM, HKEX: 13) announces that new and updated clinical
data from several ongoing combination studies of surufatinib
(SULANDA(R) in China) or fruquintinib (ELUNATE(R) 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
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 ) .[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
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
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
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
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(R) 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(R) 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 or follow us on
LinkedIn.
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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
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[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.
[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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