RCS - Hutchmed China Ltd - HUTCHMED Highlights Presentations at ASCO 2023

HUTCHMED (China)Announcement

26/05/2023 07:00

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RNS Number : 7936A  Hutchmed (China) Limited  26 May 2023

Press Release

 

HUTCHMED Highlights Presentations at the 2023 ASCO Annual Meeting

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, May 26, 2023: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that new and updated clinical data related to
HUTCHMED's novel investigational cancer therapies fruquintinib, surufatinib
and HMPL-453 in 21 abstracts that will be presented at the upcoming American
Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6,
2023 in Chicago, IL and online.

 

Fruquintinib: further analyses from the FRESCO-2 study and exploratory combination studies

 

Fruquintinib is a highly selective and potent oral inhibitor of vascular
endothelial growth factor receptor ("VEGFR")-1, -2 and -3. 1  Fruquintinib has
been generally well tolerated in patients to date and is being investigated as
a single agent and in combination with other anti-cancer therapies. 13
presentations and publications, including several
investigator-initiated-trials ("IITs"), are listed in the table below.

 

Additional FRESCO-2 analyses: New analyses from the FRESCO-2 multi-regional
clinical trial (MRCT) are being presented. FRESCO-2 is a key study supporting
ongoing and upcoming submissions to the U.S., European and Japanese regulatory
authorities for the treatment of previously treated metastatic colorectal
cancer ("CRC"). FRESCO-2 results were first presented
(https://www.hutch-med.com/fruquintinib-fresco-2-data-summary-esmo-2022/) at
the European Society for Medical Oncology Congress 2022. These new analyses
add to the understanding of fruquintinib efficacy by specific lines of therapy
as well as adverse events of special interest ("AESI"). In subgroup analyses
by prior lines of therapies up to six or more and by prior treatment with
approved agents, fruquintinib improved overall survival ("OS") and progression
free survival ("PFS") for all subgroups and prior therapies, consistent with
those of the intent-to-treat ("ITT") population. Furthermore, during the study
AESIs led to low rates of dose reduction (13.6% for patients who received
fruquintinib vs 0.9% for patients who received placebo) and dose
discontinuation (8.3% for patients who received fruquintinib vs 6.1% for
patients who received placebo).

 

CRC real-world data: Results from a prospective, 3,005-patient Phase IV study
to evaluate the safety of fruquintinib in real-world clinical practice in
China are consistent with the fruquintinib safety profile observed in existing
clinical studies, with no new or significant safety signals identified.

 

PD-1 combination in ccRCC: PFS results from an exploratory study of the
fruquintinib and sintilimab (an anti-programmed cell death protein-1  "PD-1" 
antibody) combination in metastatic clear cell renal cell carcinoma ("ccRCC")
are available with longer term follow-up. At data cut-off on November 30,
2022, median PFS was 15.9 months in 20 previously treated patients. Median PFS
was not reached when results from this study were initially presented at the
2021 Chinese Society of Clinical Oncology Annual Meeting (data cut-off on
August 31, 2021). No new safety signals were observed. A Phase II/III trial of
fruquintinib in combination with sintilimab as second-line treatment for
locally advanced or metastatic ccRCC was initiated
(https://www.hutch-med.com/fruquintinib-sintilimab-advanced-rcc/) in October
2022 (NCT05522231 (https://clinicaltrials.gov/ct2/show/NCT05522231) ).

 

IIT in 2L MSS CRC: A number of IITs are being presented, including initial
results of an IIT for fruquintinib in combination with investigator's choice
of chemotherapy in second-line metastatic CRC with microsatellite-stable (MSS)
phenotype. At median follow up of 8.4 months, median PFS was not reached in 31
efficacy evaluable patients, disease control rate (DCR) was 90.3% and
objective response rate (ORR) was 48.4%. Five patients received reduced doses
of fruquintinib.

 

Surufatinib: exploratory results in combination with other agents

 

Surufatinib is a small-molecule inhibitor of VEGFR-1, -2 and -3, fibroblast
growth factor receptor ("FGFR")-1 and colony-stimulating factor 1 receptor
(CSF-1R). Seven related presentations and publications, including IITs, are
listed in the table below.

 

PD-1 combinations: We conducted an open-label, multi-cohort, single-arm Phase
II study of surufatinib plus toripalimab (an anti-PD-1 antibody) in several
advanced solid tumors. We reported the results from the advanced thyroid
cancer and endometrial cancer cohorts (NCT04169672
(https://www.clinicaltrials.gov/ct2/show/NCT04169672) ). Amongst efficacy
evaluable radioactive iodine-refractory differentiated thyroid cancer
patients, median PFS was 10.9 months and median OS was not reached (median
follow-up duration was 22.1 months). Amongst efficacy evaluable endometrial
cancer patients, median PFS was 5.4 months and 12-month OS rate was 71.0%
(median follow-up duration was 16.8 months). In both cohorts, the combination
showed a tolerable safety profile.

 

Combo IITs: A number of IITs are being presented for surufatinib in
combination with other agents, including with chemotherapy as well as with
camrelizumab (an anti-PD-1 antibody) plus different chemotherapy regimens.

 

Preliminary results in an ongoing IIT in treatment of patients with naïve
metastatic pancreatic adenocarcinoma (PDAC) showed median PFS of 8.8 months in
patients who received a combination of surufatinib, camrelizumab,
nab-paclitaxel and S-1, compared to 5.8 months in patients who received
gemcitabine in combination with nab-paclitaxel. Markers of immune cells were
observed in an analysis of tissue samples from 13 (out of 20) patients who
received S‑1 in combination with surufatinib, camrelizumab and
nab-paclitaxel. The combination safety profiles were manageable.

 

The IIT in previously treated CRC study completed the dose escalation phase of
the study in 12 patients and enrolled a further 36 patients in the dose
expansion phase of the study. The investigators found the combination of
surufatinib with camrelizumab, irinotecan and GM-CSF to be well tolerated with
a manageable safety profile.  Median PFS was 7.2 months (95% CI 3.7-10.7).
 

 

The IIT in previously treated, advanced driver-gene negative, non-squamous,
non-small cell lung cancer ("NSCLC") in combination with chemotherapy. This
study complements Phase II results previously presented
(https://www.abstractsonline.com/pp8/#!/10828/presentation/10405) for the
surufatinib and toripalimab combination in patients with treatment naïve
advanced NSCLC with positive PD-L1 expression.

 

HMPL-453: first in human results

 

FGFRs regulate numerous cellular processes. Dysregulation of FGFR signaling
due to receptor fusion, mutation or amplification is observed across multiple
cancer types, making activated FGFRs an important therapeutic target. HMPL-453
is a highly potent and selective inhibitor of FGFR-1, -2, and -3. Preclinical
data (https://www.abstractsonline.com/pp8/#!/10828/presentation/8706)
presented at the American Association for Cancer Research Annual Meeting 2023
(AACR 2023) showed that it has strong activity against FGFR-deregulated
tumors, supporting investigation in patients with FGFR alterations (such as
fusion and mutation) either as a single agent or in combination with PD-1
blockade.

 

Here we present first-in-human data for HMPL-453 in patients with previously
treated advanced intrahepatic cholangiocarcinoma (IHCC) harboring FGFR2
fusions. A Phase II registration intent cohort is currently enrolling
(https://www.hutch-med.com/registration-phase-enrollments-of-hmpl-453-for-ihcc-and-savolitinib-for-gc-initiated/)
such patients (NCT04353375 (https://clinicaltrials.gov/ct2/show/NCT04353375)
).

 

 

Further details including the full abstracts are available at
meetings.asco.org (https://meetings.asco.org/) , as summarized below.

 

ABSTRACT PRESENTATION DETAILS

 

 Abstract title                                                                   Presenter / Lead author                                             Presentation details
 FRUQUINTINIB
 Subgroup analyses of safety and efficacy by number and types of prior lines of   Arvind Dasari, MD Anderson Cancer Center                            Abstract # 3604 (https://meetings.asco.org/abstracts-presentations/224411)
 treatment in FRESCO-2, a global phase III study of fruquintinib in patients
Poster Session
 with refractory metastatic colorectal cancer
Gastrointestinal Cancer-Colorectal and Anal

Monday, June 5, 2023, 8 am CDT, Hall A
 Analysis of fruquintinib adverse events of special interest from phase 3 of      Cathy Eng, Vanderbilt-Ingram Cancer Center                          Abstract # 3601 (https://meetings.asco.org/abstracts-presentations/224409)
 the FRESCO-2 study
Poster Session

Gastrointestinal Cancer-Colorectal and Anal

Monday, June 5, 2023, 8 am CDT, Hall A
 A phase IV study to evaluate the safety of fruquintinib in Chinese real-world    Jin Li, Tongji University Shanghai East Hospital                    Abstract # e15568 (https://meetings.asco.org/abstracts-presentations/225245)
 clinical practice
Publication Only

Gastrointestinal Cancer-Colorectal and Anal
 Fruquintinib plus sintilimab in patients with either treatment-naive or          Dingwei Ye, Fudan University Shanghai Cancer Center                 Abstract # e16514 (https://meetings.asco.org/abstracts-presentations/222340)
 previously first line treated metastatic clear-cell renal cell carcinoma
Publication Only
 (ccRCC): Results from a multicenter, single-arm phase 2 study
Genitourinary Cancer-Kidney and Bladder
 Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy   Wensi Zhao, Renmin Hospital of Wuhan University                     Abstract # 3582 (https://meetings.asco.org/abstracts-presentations/224368)
 as second-line therapy in metastatic colorectal cancer: A multicenter,
Poster Session
 single-arm phase 2 trial
Gastrointestinal Cancer-Colorectal and Anal

Monday, June 5, 2023, 8 am CDT, Hall A
 Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy     Liucheng Wu, Guangxi Medical University Cancer Hospital             Abstract # e16063 (https://meetings.asco.org/abstracts-presentations/222005)
 for locally advanced gastric adenocarcinoma (FRUTINEOGA): a multicenter, phase                                                                       Publication Only
 II study.                                                                                                                                            Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
 Association of neutrophil/lymphocyte ratio and IFN-γ with clinical response      Zhuqing Liu, Tongji University School of Medicine                   Abstract # e14610 (https://meetings.asco.org/abstracts-presentations/224907)
 and survival in patients with MSS/pMMR mCRC treated with anti-PD-1 and VEGF                                                                          Publication Only
 inhibitors                                                                                                                                           Developmental Therapeutics-Immunotherapy
 Efficacy and safety of radiation therapy combined with anti-angiogenic agents    Zhenyu Lin, Tongji Medical College                                  Abstract # e15559 (https://meetings.asco.org/abstracts-presentations/225228)
 and immunotherapy for MSS/pMMR metastatic colorectal cancer: A real-world                                                                            Publication Only
 study                                                                                                                                                Gastrointestinal Cancer-Colorectal and Anal
 A phase II study of fruquintinib in the first- (1L) or second-line (2L)          Zhiguo Luo, Fudan University Shanghai Cancer Center                 Abstract # e23547 (https://meetings.asco.org/abstracts-presentations/220855)
 treatment of unresectable metastatic soft tissue sarcoma                                                                                             Publication Only
                                                                                                                                                      Sarcoma
 Quality of life, effectiveness, and compliance of fruquintinib in the            Jun Zhang, Reijin Hospital                                          Abstract # e15557 (https://meetings.asco.org/abstracts-presentations/225219)
 treatment of metastatic colorectal cancer: Results from a prospective                                                                                Publication Only
 real-world study.
Gastrointestinal Cancer-Colorectal and Anal
 Fruquintinib versus fruquintinib combined with PD-1 inhibitors for metastatic    Lina He, Shanghai Jiao Tong University                              Abstract # e15592 (https://meetings.asco.org/abstracts-presentations/225295)
 colorectal cancer: Real-world data                                                                                                                   Publication Only

Gastrointestinal Cancer-Colorectal and Anal
 Phase II study of fruquintinib as second or further-line therapy for patients    Pengfei Zhang, West China Hospital                                  Abstract # e16161 (https://meetings.asco.org/abstracts-presentations/222117)
 with advanced biliary tract cancer                                                                                                                   Publication Only
                                                                                                                                                      Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
 A phase I/IIa study of cetuximab combined with fruquintinib in the previously    Yong Li, Traditional Chinese Medicine Hospital of Guangdong         Abstract # e15558 (https://meetings.asco.org/abstracts-presentations/225222)
 treated RAS/BRAF wild-type metastatic colorectal cancer: Results of the CEFRU                                                                        Publication Only
 study                                                                                                                                                Gastrointestinal Cancer-Colorectal and Anal
 SURUFATINIB
 A multicenter, single-arm phase 2 study of surufatinib plus toripalimab for      Dongmei Ji, Fudan University Shanghai Cancer Center                 Abstract # 6089 (https://meetings.asco.org/abstracts-presentations/218570)
 patients with locally advanced or metastatic radioactive iodine-refractory
Poster Session
 differentiated thyroid cancer
Head and Neck Cancer

Monday, June 5, 2023, 1:15 pm CDT, Hall A
 A multicenter, single-arm, phase 2 study of surufatinib plus toripalimab for     Guangwen Yuan, Cancer Hospital Chinese Academy of Medical Sciences  Abstract # 5609 (https://meetings.asco.org/abstracts-presentations/223054)
 patients with advanced endometrial cancer
Poster Session

Gynecologic Cancer

Monday, June 5, 2023, 1:15 pm CDT, Hall A
 A phase 1b/2 study of surufatinib plus camrelizumab, nab-paclitaxel, and S-1     Guanghai Dai, The Fifth Medical Center of the PLA General Hospital  Abstract # 4142 (https://meetings.asco.org/abstracts-presentations/226583)
 (NASCA) as first-line therapy for metastatic pancreatic adenocarcinoma (mPDAC)
Poster Session

Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary

Monday, June 5, 2023, 8:00 am CDT, Hall A
 A phase Ib/II study to evaluate surufatinib combined with camrelizumab and       Sheng Li, Department of Oncology, Jiangsu Cancer Hospital           Abstract # 3555 (https://meetings.asco.org/abstracts-presentations/224337)
 chemotherapy in the second-line treatment of advanced colorectal cancer: Phase
Poster Session
 Ib results
Gastrointestinal Cancer-Colorectal and Anal

Monday, June 5, 2023, 8 am CDT, Hall A
 Phase 1b/2 study of surufatinib in combination with docetaxel as second-line     Wei Jiang, Guangxi Medical University Cancer Hospital               Abstract # e21087 (https://meetings.asco.org/abstracts-presentations/219019)
 treatment of advanced driver-gene negative non-squamous non-small cell lung
Publication Only
 cancer (NSCLC)
Lung Cancer-Non-Small Cell Metastatic
 Pathologic exploration of neuroendocrine differentiation in carcinomas           Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences       Abstract # (https://meetings.asco.org/abstracts-presentations/222061)
                                                                                                                                                      (https://meetings.asco.org/abstracts-presentations/222061) e16238
                                                                                                                                                      (https://meetings.asco.org/abstracts-presentations/222061)
                                                                                                                                                      Publication Only
                                                                                                                                                      Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
 A phase II study of surufatinib in patients with osteosarcoma and soft tissue    Xing Zhang, Sun Yat-sen University Cancer Center                    Abstract # (https://meetings.asco.org/abstracts-presentations/220845)
 sarcoma who have failed in standard chemotherapy                                                                                                     (https://meetings.asco.org/abstracts-presentations/220845) e23540
                                                                                                                                                      (https://meetings.asco.org/abstracts-presentations/220845)
                                                                                                                                                      Publication Only
                                                                                                                                                      Sarcoma
 HMPL-453
 A phase 2 study of HMPL-453, a selective FGFR tyrosine kinase inhibitor (TKI),   Jianming Xu, Fifth Medical Center, Chinese PLA General Hospital     Abstract # e16118 (https://meetings.asco.org/abstracts-presentations/222135)
 in patients with previously treated advanced cholangiocarcinoma containing
Publication Only
 FGFR2 fusions
Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepato-biliary

 

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 approximately
5,000 personnel across all its companies, at the center of which is a team of
about 1,800 in oncology/immunology. Since inception it has focused on bringing
cancer drug candidates from in-house discovery to patients 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 fruquintinib, surufatinib, and HMPL-453, the further
clinical development for fruquintinib, surufatinib, and HMPL-453, its
expectations as to whether any studies on fruquintinib, surufatinib and
HMPL-453 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
fruquintinib, surufatinib and HMPL-453, 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 fruquintinib,
surufatinib and HMPL-453 for a targeted indication; the sufficiency of
funding; and the impact of the COVID-19 pandemic on general economic,
regulatory and political conditions. 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) 306 4490

 Media Enquiries
 Americas - Brad Miles, Solebury Strategic Communications         +1 (917) 570 7340 (Mobile) / bmiles@s (mailto:bmiles@soleburystrat.com)
                                                                  oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                                  (mailto:bmiles@soleburystrat.com)
 Europe - Ben Atwell / Alex Shaw, FTI Consulting                  +44 20 3727 1030 / +44 7771 913 902 (Mobile) /
                                                                  +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
                                                                  (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                                        +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                  (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon  +44 (20) 7886 2500

 

 1  Sun Q, et al. (2014) Discovery of fruquintinib, a potent and highly
selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for
cancer therapy, Cancer Biol Ther. 2014 15:12, 1635-1645. Doi:
10.4161/15384047.2014.964087

 

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