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HUTCHMED China Limited | NASDAQ:HCM | NASDAQ | Depository Receipt |
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TIDMHCM
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") (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 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 in October 2022 (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). 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 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 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 such patients (NCT04353375).
Further details including the full abstracts are available at meetings.asco.org , as summarized below.
ABSTRACT PRESENTATION DETAILS
Abstract title Presenter / Lead author Presentation details ====================================== ====================================== ====================================== FRUQUINTINIB ====================================== ====================================== ====================================== Subgroup analyses of safety and Arvind Dasari, MD Anderson Cancer Abstract # 3604 efficacy by number and types of prior Center Poster Session lines of treatment Gastrointestinal Cancer-Colorectal and in FRESCO-2, a global phase III study Anal of fruquintinib in patients with Monday, June 5, 2023, 8 am CDT, Hall A refractory metastatic colorectal cancer ====================================== ====================================== ====================================== Analysis of fruquintinib adverse Cathy Eng, Vanderbilt-Ingram Cancer Abstract # 3601 events of special interest from phase Center Poster Session 3 of the FRESCO-2 Gastrointestinal Cancer-Colorectal and study Anal Monday, June 5, 2023, 8 am CDT, Hall A ====================================== ====================================== ====================================== A phase IV study to evaluate the Jin Li, Tongji University Shanghai Abstract # e15568 safety of fruquintinib in Chinese East Hospital Publication Only real-world clinical practice Gastrointestinal Cancer-Colorectal and Anal ====================================== ====================================== ====================================== Fruquintinib plus sintilimab in Dingwei Ye, Fudan University Shanghai Abstract # e16514 patients with either treatment-naive Cancer Center Publication Only or previously first Genitourinary Cancer-Kidney and line treated metastatic clear-cell Bladder renal cell carcinoma (ccRCC): Results from a multicenter, single-arm phase 2 study
====================================== ====================================== ====================================== Efficacy and safety of fruquintinib Wensi Zhao, Renmin Hospital of Wuhan Abstract # 3582 plus investigator's choice of University Poster Session chemotherapy as second-line Gastrointestinal Cancer-Colorectal and therapy in metastatic colorectal Anal cancer: A multicenter, single-arm Monday, June 5, 2023, 8 am CDT, Hall A phase 2 trial ====================================== ====================================== ====================================== Fruquintinib plus oxaliplatin combined Liucheng Wu, Guangxi Medical Abstract # e16063 with S-1 (SOX) as neoadjuvant therapy University Cancer Hospital Publication Only for locally Gastrointestinal advanced gastric adenocarcinoma Cancer-Gastroesophageal, Pancreatic, (FRUTINEOGA): a multicenter, phase II and Hepatobiliary study. ====================================== ====================================== ====================================== Association of neutrophil/lymphocyte Zhuqing Liu, Tongji University School Abstract # e14610 ratio and IFN-<GAMMA> with clinical of Medicine Publication Only response and survival Developmental in patients with MSS/pMMR mCRC treated Therapeutics-Immunotherapy with anti-PD-1 and VEGF inhibitors ====================================== ====================================== ====================================== Efficacy and safety of radiation Zhenyu Lin, Tongji Medical College Abstract # e15559 therapy combined with anti-angiogenic Publication Only agents and immunotherapy Gastrointestinal Cancer-Colorectal and for MSS/pMMR metastatic colorectal Anal cancer: A real-world study ====================================== ====================================== ====================================== A phase II study of fruquintinib in Zhiguo Luo, Fudan University Shanghai Abstract # e23547 the first- (1L) or second-line (2L) Cancer Center Publication Only treatment of unresectable Sarcoma metastatic soft tissue sarcoma ====================================== ====================================== ====================================== Quality of life, effectiveness, and Jun Zhang, Reijin Hospital Abstract # e15557 compliance of fruquintinib in the Publication Only treatment of metastatic Gastrointestinal Cancer-Colorectal and colorectal cancer: Results from a Anal prospective real-world study. ====================================== ====================================== ====================================== Fruquintinib versus fruquintinib Lina He, Shanghai Jiao Tong University Abstract # e15592 combined with PD-1 inhibitors for Publication Only metastatic colorectal Gastrointestinal Cancer-Colorectal and cancer: Real-world data Anal ====================================== ====================================== ====================================== Phase II study of fruquintinib as Pengfei Zhang, West China Hospital Abstract # e16161 second or further-line therapy for Publication Only patients with advanced Gastrointestinal biliary tract cancer Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary ====================================== ====================================== ====================================== A phase I/IIa study of cetuximab Yong Li, Traditional Chinese Medicine Abstract # e15558 combined with fruquintinib in the Hospital of Guangdong Publication Only previously treated RAS/BRAF Gastrointestinal Cancer-Colorectal and wild-type metastatic colorectal Anal cancer: Results of the CEFRU study ====================================== ====================================== ====================================== SURUFATINIB ====================================== ====================================== ====================================== A multicenter, single-arm phase 2 Dongmei Ji, Fudan University Shanghai Abstract # 6089 study of surufatinib plus toripalimab Cancer Center Poster Session for patients with Head and Neck Cancer locally advanced or metastatic Monday, June 5, 2023, 1:15 pm CDT, radioactive iodine-refractory Hall A differentiated thyroid cancer ====================================== ====================================== ====================================== A multicenter, single-arm, phase 2 Guangwen Yuan, Cancer Hospital Chinese Abstract # 5609 study of surufatinib plus toripalimab Academy of Medical Sciences Poster Session for patients with Gynecologic Cancer advanced endometrial cancer Monday, June 5, 2023, 1:15 pm CDT, Hall A ====================================== ====================================== ====================================== A phase 1b/2 study of surufatinib plus Guanghai Dai, The Fifth Medical Center Abstract # 4142 camrelizumab, nab-paclitaxel, and S-1 of the PLA General Hospital Poster Session (NASCA) as first-line Gastrointestinal therapy for metastatic pancreatic Cancer-Gastroesophageal, Pancreatic, adenocarcinoma (mPDAC) and Hepatobiliary Monday, June 5, 2023, 8:00 am CDT, Hall A ====================================== ====================================== ====================================== A phase Ib/II study to evaluate Sheng Li, Department of Oncology, Abstract # 3555 surufatinib combined with camrelizumab Jiangsu Cancer Hospital Poster Session and chemotherapy in Gastrointestinal Cancer-Colorectal and the second-line treatment of advanced Anal colorectal cancer: Phase Ib results Monday, June 5, 2023, 8 am CDT, Hall A ====================================== ====================================== ====================================== Phase 1b/2 study of surufatinib in Wei Jiang, Guangxi Medical University Abstract # e21087 combination with docetaxel as Cancer Hospital Publication Only second-line treatment of Lung Cancer-Non-Small Cell Metastatic advanced driver-gene negative non-squamous non-small cell lung cancer (NSCLC) ====================================== ====================================== ====================================== Pathologic exploration of Yaru Wen, Cancer Hospital Chinese Abstract # e16238 neuroendocrine differentiation in Academy of Medical Sciences Publication Only carcinomas Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary ====================================== ====================================== ====================================== A phase II study of surufatinib in Xing Zhang, Sun Yat-sen University Abstract # e23540 patients with osteosarcoma and soft Cancer Center Publication Only tissue sarcoma who Sarcoma have failed in standard chemotherapy ====================================== ====================================== ====================================== HMPL-453 ====================================== ====================================== ====================================== A phase 2 study of HMPL-453, a Jianming Xu, Fifth Medical Center, Abstract # e16118 selective FGFR tyrosine kinase Chinese PLA General Hospital Publication Only inhibitor (TKI), in patients Gastrointestinal
with previously treated advanced Cancer-Gastroesophageal, Pancreatic, cholangiocarcinoma containing FGFR2 and Hepato-biliary fusions ====================================== ====================================== ======================================
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 or follow us on LinkedIn.
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 oleburystrat .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 Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / 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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May 26, 2023 02:00 ET (06:00 GMT)
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