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Clinical Data to be Presented at ESMO and WCLC

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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") (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 titlePresenter / Lead authorPresentation details
WCLC24 - INVESTIGATOR-INITIATED STUDIES
Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm advanced NSCLC (CTONG 2008): A Phase II trialJin j i Yang , Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital , Southern Medical University, Guangzhou, ChinaPL04.10 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 Multiple Distant Organ Metastatic ES-SCLCYingying Du, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Hesheng Qian, Fuyang Cancer Hospital, Fuyang, ChinaEP.13A.04A ePoster Saturday, September 7, 2024
Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Non-Squamous NSCLC: A Phase Ib/II StudyQitao Yu, Wei Jiang, Guangxi Medical University Cancer Hospital, Nanning, ChinaP3.12C.08 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 titlePresenter / Lead authorPresentation details
ESMO 2024 - SPONSORED STUDIES
Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase 3 FRESCO-2 trialRocio Garcia-Carbonero , Hospital Universitario 12 de Octubre, lmas12, UCM, Madrid, Spain520P Poster Session - Colorectal cancer Monday, 16 September 2024
Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: A FRESCO-2 subgroup analysis by ageMaria Elena Elez Fernandez , Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain526P Poster Session - Colorectal cancer Monday, 16 September 2024
Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior immunotherapy (prior-IO): subgroup analysis from FRUTIGA studyLin Shen , Peking University Cancer Hospital & Institute, Beijing, China1410P Poster Session - Oesophagogastric cancer Monday, 16 September 2024
Impact of subsequent anti-tumor therapies in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma receiving fruquintinib (F) plus paclitaxel (PTX) or placebo plus PTX in FRUTIGA studyRui h ua Xu , Sun Yat-sen University Cancer Center, Guangzhou, China1434P Poster Session - Oesophagogastric cancer Monday, 16 September 2024
Association between Fruquintinib-induced Hypertension and Clinical Outcomes from FRUTIGA, a Phase 3 Study of Fruquintinib plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) AdenocarcinomaShukui Qin , Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China1443P Poster Session - Oesophagogastric cancer Monday, 16 September 2024
Analysis of MET gene alterations in cfDNA samples from a phase II study of savolitinib in patients (pts) with MET-amplified gastroesophageal junction adenocarcinomas or gastric cancer (GEJ/GC)Zhi Peng , Peking University Cancer Hospital & Institute, Beijing, China14 61 P Poster Session - Oesophagogastric cancer Monday, 16 September 2024
ESMO 2024 - INVESTIGATOR-INITIATED STUDIES
A phase II clinical study of fruquintinib (Fru) combined with toripalimab (Tor) and short-course radiotherapy (SCRT) as neoadjuvant therapy for locally advanced rectal cancer (LARC)Zhiping Li, Ye Chen , West China Hospital of Sichuan University, Chengdu, China570P Poster Session - Colorectal cancer Monday, 16 September 2024
Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Updated findings from a single-arm, prospective phase II trial (RIFLE)Zhen Zhang, Yajie Chen, Fudan University Shanghai Cancer Center, Shanghai, China537P Poster Session - Colorectal cancer Monday, 16 September 2024
Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated resultsYongqian Shu , Pei M a, Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing, China1329P Poster Session - NSCLC, metastatic Saturday, 14 September 2024
Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)Xiaobing Chen, Bei b ei Chen , Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China1475TiP Poster Session - Oesophagogastric cancer Monday, 16 September 2024
Fruquintinib combined with nab-paclitaxel and gemcitabine (AG) as the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) with liver metastases: An open-label, single-arm, single-center phase II clinical studyXianjun Yu, Miaoyan Wei , Fudan University Shanghai Cancer Center, Shanghai, China1529P Poster Session - Pancreatic cancer Monday, 16 September 2024
A phase II study of Fruquintinib in the 1L or 2L treatment of unresectable metastatic soft tissue sarcomaZhiguo Luo , Xiaowei Zhang , Fudan University Shanghai Cancer Center, Shanghai, China1743P Poster Session - Sarcoma Saturday, 14 September 2024
Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II studyFuxiang Zhou , Zhongnan Hospital, Wuhan University, Wuhan, China974P Poster Session - Hepatocellular carcinoma (HCC) Monday, 16 September 2024
Updated results of Surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao , West China Hospital, Sichuan University, Chengdu, China1155P Poster Session - Neuroendocrine tumours Monday, 16 September 2024
Surufatinib plus toripalimab combined with pemetrexed (A), and platinum (P) in patients (pts) with advanced non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a single-center, phase II trialLi Zhang, Wen f eng Fang , Sun Yat-Sen University Cancer Center, Guangzhou, China1345P Poster Session - NSCLC, metastatic Saturday, 14 September 2024
Surufatinib combined with gemcitabine in soft tissue sarcoma (STS) patients failed with anthracyclines chemotherapy or monotherapy post-anlotinib progression: a multi-center, phase II trialXiaohui Niu, Yuhong Zhou , Zhongshan Hospital, Fudan University, Shanghai, China1740P Poster Session - Sarcoma Saturday, 14 September 2024

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