RCS - Hutchmed China Ltd - Clinical Data to be Presented at ESMO and WCLC
09/09/2024 07:00
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RNS Number : 2462D Hutchmed (China) Limited 09 September 2024
Press Release
HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer
Hong Kong, Shanghai & Florham Park, NJ - Monday, September 9, 2024:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from
several studies of compounds discovered by HUTCHMED will be presented at the
2024 World Conference on Lung Cancer ("WCLC24") in San Diego, USA, and the
European Society for Medical Oncology ("ESMO") Congress 2024, taking place in
Barcelona, Spain.
Results from the FLOWERS study, a prospective, two-arm, randomized,
multicenter Phase II clinical trial of osimertinib with or without savolitinib
as first-line treatment in EGFRm, MET-aberrant advanced non-small cell lung
cancer ("NSCLC") patients, will be presented at WCLC24. As of May 28, 2024,
the median follow-up was 8.2 months. Patients treated with osimertinib plus
savolitinib (Cohort 2, N=21) showed deeper and more durable response over
osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. The
confirmed objective response rate (ORR) in Cohort 1 and Cohort 2 were 60.9%
and 90.5%, respectively, with disease control rate (DCR) of 87% and 95.2%,
respectively. Immature progression-free survival ("PFS") data also showed a
positive trend in favor of the combination therapy, with median PFS of 9.3
months and 19.6 months in the cohort 1 and cohort 2 with maturity of 34.8% and
23.8%, respectively. Safety profiles of osimertinib monotherapy and
osimertinib plus savolitinib were as expected, tolerable and manageable.
Abstract title Presenter / Lead author Presentation details
WCLC24 - INVESTIGATOR-INITIATED STUDIES
Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm Jinji Yang, PL04.10 (https://cattendee.abstractsonline.com/meeting/20598/Session/79)
advanced NSCLC (CTONG 2008): A Phase II trial Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital,
Southern Medical University, Guangzhou, China Plenary Session
PL04 Presidential Symposium 2,
Plenary Hall
Monday, September 9, 2024 at
8:30 AM PDT
Study of Surufatinib Combined with Low Dose Topotecan in Second or Third-Line Yingying Du, The First Affiliated Hospital of Anhui Medical University, Hefei, EP.13A.04A (https://cattendee.abstractsonline.com/meeting/20598/Session/328)
Multiple Distant Organ Metastatic ES-SCLC China; Hesheng Qian, Fuyang Cancer Hospital, Fuyang, China
ePoster
Saturday, September 7, 2024
Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Qitao Yu, Wei Jiang, P3.12C.08 (https://cattendee.abstractsonline.com/meeting/20598/Session/281)
Non-Squamous NSCLC: A Phase Ib/II Study
Guangxi Medical University Cancer Hospital, Nanning, China
Poster
Monday, September 9, 2024 at
8:30 AM PDT
Further analysis of fruquintinib's FRESCO-2 study in metastatic colorectal
cancer and FRUTIGA study in gastric cancer, a biomarker study of savolitinib
in gastric cancer as well as investigator-initiated studies of fruquintinib
and surufatinib will be presented at the ESMO Congress 2024. Details of the
presentations are as follows:
Abstract title Presenter / Lead author Presentation details
ESMO 2024 - SPONSORED STUDIES
Efficacy and safety of fruquintinib in patients with refractory metastatic Rocio Garcia-Carbonero, 520P
colorectal cancer with and without liver metastasis: A subgroup analysis of
the phase 3 FRESCO-2 trial Hospital Universitario 12 de Octubre, lmas12, UCM, Madrid, Spain Poster Session - Colorectal cancer
Monday, 16 September 2024
Efficacy and safety of fruquintinib in refractory metastatic colorectal Maria Elena Elez Fernandez, 526P
cancer: A FRESCO-2 subgroup analysis by age
Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Poster Session - Colorectal cancer
Barcelona, Spain
Monday, 16 September 2024
Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior Lin Shen, 1410P
immunotherapy (prior-IO): subgroup analysis from FRUTIGA study
Peking University Cancer Hospital & Institute, Beijing, China Poster Session - Oesophagogastric cancer
Monday, 16 September 2024
Impact of subsequent anti-tumor therapies in patients (pts) with advanced Ruihua Xu, 1434P
gastric or gastroesophageal junction (G/GEJ) adenocarcinoma receiving
fruquintinib (F) plus paclitaxel (PTX) or placebo plus PTX in FRUTIGA study Sun Yat-sen University Cancer Center, Guangzhou, China Poster Session - Oesophagogastric cancer
Monday, 16 September 2024
Association between Fruquintinib-induced Hypertension and Clinical Outcomes Shukui Qin, 1443P
from FRUTIGA, a Phase 3 Study of Fruquintinib plus Paclitaxel in Previously
Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Poster Session - Oesophagogastric cancer
Nanjing, China
Monday, 16 September 2024
Analysis of MET gene alterations in cfDNA samples from a phase II study Zhi Peng, 1461P
of savolitinib in patients (pts) with MET-amplified gastroesophageal
junction adenocarcinomas or gastric cancer (GEJ/GC) Peking University Cancer Hospital & Institute, Beijing, China Poster Session - Oesophagogastric cancer
Monday, 16 September 2024
ESMO 2024 - INVESTIGATOR-INITIATED STUDIES
A phase II clinical study of fruquintinib (Fru) combined with toripalimab Zhiping Li, Ye Chen, 570P
(Tor) and short-course radiotherapy (SCRT) as neoadjuvant therapy for locally
advanced rectal cancer (LARC) West China Hospital of Sichuan University, Chengdu, China Poster Session - Colorectal cancer
Monday, 16 September 2024
Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab Zhen Zhang, Yajie Chen, 537P
in metastatic colorectal cancer: Updated findings from a single-arm,
prospective phase II trial (RIFLE) Fudan University Shanghai Cancer Center, Shanghai, China Poster Session - Colorectal cancer
Monday, 16 September 2024
Fruquintinib combined with sintilimab and chemotherapy as the first-line Yongqian Shu, Pei Ma, 1329P
treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small
cell lung cancer (nsq-NSCLC): Updated results Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical Poster Session - NSCLC, metastatic
University, Nanjing, China
Saturday, 14 September 2024
Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment Xiaobing Chen, Beibei Chen, 1475TiP
for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)
Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Poster Session - Oesophagogastric cancer
Zhengzhou, China
Monday, 16 September 2024
Fruquintinib combined with nab-paclitaxel and gemcitabine (AG) as the Xianjun Yu, Miaoyan Wei, 1529P
first-line treatment for pancreatic ductal adenocarcinoma (PDAC) with liver
metastases: An open-label, single-arm, single-center phase II clinical study Fudan University Shanghai Cancer Center, Shanghai, China Poster Session - Pancreatic cancer
Monday, 16 September 2024
A phase II study of Fruquintinib in the 1L or 2L treatment of unresectable Zhiguo Luo, Xiaowei Zhang, 1743P
metastatic soft tissue sarcoma
Fudan University Shanghai Cancer Center, Shanghai, China Poster Session - Sarcoma
Saturday, 14 September 2024
Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or Fuxiang Zhou, 974P
monotherapy in third line treatment of advanced hepatocellular carcinoma: A
single-arm, open-label, multi-center phase II study Zhongnan Hospital, Wuhan University, Wuhan, China Poster Session - Hepatocellular carcinoma (HCC)
Monday, 16 September 2024
Updated results of Surufatinib plus transarterial embolization Dan Cao, 1155P
versus surufatinib monotherapy in neuroendocrine tumor with liver
metastasis: a prospective, randomized, controlled trial West China Hospital, Sichuan University, Chengdu, China Poster Session - Neuroendocrine tumours
Monday, 16 September 2024
Surufatinib plus toripalimab combined with pemetrexed (A), and platinum (P) Li Zhang, Wenfeng Fang, 1345P
in patients (pts) with advanced non-squamous non-small cell lung cancer
(nsq-NSCLC): Updated results of a single-center, phase II trial Sun Yat-Sen University Cancer Center, Guangzhou, China Poster Session - NSCLC, metastatic
Saturday, 14 September 2024
Surufatinib combined with gemcitabine in soft tissue sarcoma (STS) patients Xiaohui Niu, Yuhong Zhou, 1740P
failed with anthracyclines chemotherapy or monotherapy post-anlotinib
progression: a multi-center, phase II trial Zhongshan Hospital, Fudan University, Shanghai, China Poster Session - Sarcoma
Saturday, 14 September 2024
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. 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, HUTCHMED has focused on
bringing cancer drug candidates from in-house discovery to patients around the
world, with its first three medicines marketed in China, the first of which is
also marketed in the US and Europe. 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 reflect HUTCHMED's current
expectations regarding future events, including but not limited to its
expectations regarding the therapeutic potential of fruquintinib, savolitinib
and surufatinib, the further clinical development for fruquintinib,
savolitinib and surufatinib, its expectations as to whether any studies on
fruquintinib, savolitinib and surufatinib, 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. 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, savolitinib and
surufatinib, including as combination therapies, 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 markets of fruquintinib, savolitinib and surufatinib
for a targeted indication, and the sufficiency of funding. In addition, as
certain studies rely on the use of CAPEOX, docetaxel, gemcitabine,
nab-paclitaxel, paclitaxel, pemetrexed, platinum, sintilimab, topotecan,
tislelizumab or toripalimab as combination therapeutics, such risks and
uncertainties include assumptions regarding their safety, efficacy, supply and
continued regulatory approval. 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.
Medical Information
This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.
CONTACTS
Investor Enquiries +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)
Media Enquiries
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)
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
(mailto:HUTCHMED@brunswickgroup.com)
Nominated Advisor
Atholl Tweedie / Freddy Crossley / +44 (20) 7886 2500
Rupert Dearden, Panmure Liberum
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