Surufatinib

The recent 40% drop in Alphamab Oncology's stock price following the failure of its Phase III clinical trial for KN046 in the treatment of advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) has sent shockwaves through the oncology community. Pancreatic cancer, often referred to as the "King of Cancers," has long been a formidable challenge, with limited effective treatment options and dismal survival rates. However, Alphamab Oncology's setback has not dampened the industry's efforts to find breakthrough therapies for this deadly disease. Unmet Clinical Needs in Pancreatic Cancer: Pancreatic cancer is a highly aggressive malignancy, characterized by rapid progression, early metastasis, and a low early detection rate. Less than 5-7% of patients are diagnosed in the early stages, and more than 80% lose the opportunity for surgical resection by the time of diagnosis. Current first-line treatment regimens, such as the combination of gemcitabine and albumin-bound paclitaxel, offer a median overall survival (OS) of only 6-9 months, highlighting the significant unmet clinical needs in this disease. Promising Investigational Therapies: Despite the recent setback, the pipeline for pancreatic cancer treatments remains promising. Several pharmaceutical companies are actively exploring innovative approaches to address this challenge. For instance, Hutchison MediPharma has initiated a Phase II/III clinical trial to evaluate the combination of the tyrosine kinase inhibitor surufatinib, the PD-1 antibody carrelizumab, and gemcitabine plus albumin-bound paclitaxel as a first-line treatment for PDAC. Moreover, Innovent Biologics has reported promising early-stage data for its anti-CLDN18.2/CD3 bispecific antibody IBI389 and anti-Claudin18.2 antibody-drug conjugate IBI343 in the treatment of advanced pancreatic cancer. These targeted therapies aim to harness the power of the immune system and deliver cytotoxic payloads directly to cancer cells, potentially offering new hope for patients. Overcoming Setbacks and Driving Innovation: The failure of Alphamab Oncology's KN046 trial is a sobering reminder of the challenges faced in the development of new cancer treatments. However, the industry's unwavering commitment to advancing the field of pancreatic cancer research is evident. Companies are diligently analyzing the data from their clinical trials, identifying areas for improvement, and refining their approaches to overcome these setbacks. The battle against the "King of Cancers" is far from over. While the recent disappointment with Alphamab Oncology's KN046 trial is a setback, it has not dampened the industry's determination to find more effective treatments for pancreatic cancer. With a robust pipeline of investigational therapies and a renewed focus on innovation, the oncology community remains dedicated to improving outcomes for patients suffering from this devastating disease.

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 23, 2024 (GLOBE NEWSWIRE) -- 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 upcoming American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL and online. Results will be presented from the registration Phase II study of fruquintinib combined with sintilimab in 98 second-line or above patients with endometrial cancer (“EMC”) with pMMR status by central laboratory analysis, which supported the New Drug Application (NDA) filed in China. The primary endpoint was objective response rate (“ORR”) per RECIST v1.1, assessed by an independent review committee. The combination showed meaningful efficacy improvements in advanced EMC patients with pMMR status, regardless of prior bevacizumab treatment, with a manageable safety profile. The median follow-up time was 15.7 months. The ORR in 87 efficacy evaluable patients was 35.6% including two complete responses. Disease control rate (“DCR”) was 88.5%, and duration of response was not reached, with 80.7% remaining in response after nine months. Amongst the 98 patients, median progression-free survival (PFS) was 9.5 months, and median overall survival (OS) was 21.3 months. Further details are available in the abstract link below. Following the initial data of the FRUTIGA Phase III study of fruquintinib in second-line gastric cancer published during the February 2024 ASCO Plenary Series session, further updated efficacy data in key subgroups, and quality of life data will be presented at this year’s ASCO annual meeting. In addition, further data from the FRESCO and FRESCO-2 Phase III colorectal cancer studies, the study of surufatinib combinations in small cell lung cancer, and initial clinical data for the ERK1/2 inhibitor HMPL-295 will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES Fruquintinib plus Sintilimab in Treated Advanced Endometrial Cancer (EMC) Patients (Pts) with pMMR Status: Results From a Multicenter, Single-Arm Phase 2 StudyXiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China#5619Poster Session - Gynecologic CancerEfficacy and safety of fruquintinib in patients with metastatic colorectal cancer according to prior treatment sequence in the refractory setting: Results from FRESCO and FRESCO-2Tanios S. Bekaii-Saab, Mayo Clinic, U.S.#3579Poster Session - Gastrointestinal Cancer — Colorectal and AnalFruquintinib in Refractory Metastatic Colorectal CancerCathy Eng, Vanderbilt-Ingram Cancer Center, U.S.LinkEducation Session: New Drugs in Oncology: Incorporation Into PracticeUpdates on Abstract 438730: Fruquintinib Plus Paclitaxel Versus Paclitaxel as Second-Line Therapy for Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (FRUTIGA): A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 StudyFeng Wang, Sun Yat-Sen University Cancer Center, Guangzhou, ChinaLinkEducation Session: ASCO Plenary Series: Rapid Abstract UpdatesSurufatinib plus PD-1/L1 inhibitors as maintenance therapy following first line (1L) platinum-based chemotherapy combined with PD-1/L1 inhibitors in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC)Yi Hu,Chinese PLA General Hospital, Beijing, China#e15109Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologyFirst-in-human study of HMPL-295, an ERK1/2 inhibitor, in patients with advanced solid tumors: dose-escalation results of monotherapyXianjun Yu,Fudan University Shanghai Cancer Center, Shanghai, China#e15112Publication Only: Developmental Therapeutics—Molecularly Targeted Agents and Tumor BiologyINVESTIGATOR-INITIATED STUDIES Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)Chen Yajie, Zhang Zhen,Fudan University Shanghai Cancer Center, Shanghai, China#e15570Publication Only: Gastrointestinal Cancer—Colorectal and AnalA propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world dataLina He, Shuiping Tu,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China#e15564 Publication Only: Gastrointestinal Cancer—Colorectal and AnalPhase Ib/II trial of hepatic arterial infusion chemotherapy (HAIC) in combination with fruquintinib as third-line therapy for refractory unresectable colorectal cancer liver metastasesZhu Xu,Peking University Cancer Hospital and Institute, Beijing, China#3561Poster Session - Gastrointestinal Cancer—Colorectal and AnalEfficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter studyJianjun Peng,The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China#3536Poster Session - Gastrointestinal Cancer — Colorectal and AnalA phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survivalLu Wang, Zhang Ti,Fudan University Shanghai Cancer Center, Shanghai, China#3543Poster Session - Gastrointestinal Cancer — Colorectal and AnalFruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trialSuxia Luo, Fei Ma,Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China#e16021Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliaryShort-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II studyTao Zhang, Zhenyu Lin,Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaTPS3643Poster Session: Gastrointestinal Cancer — Colorectal and AnalFruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II studyJunjie Peng, Wenhua Li,Fudan University Shanghai Cancer Center, Shanghai, China#3567Poster Session: Gastrointestinal Cancer — Colorectal and AnalEfficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trialYongshun Chen, Wensi Zhao,Renmin Hospital of Wuhan University, Wuhan, China#3571Poster Session: Gastrointestinal Cancer — Colorectal and AnalComparative analysis of first-line therapy with fruquintinib plus chemotherapy versus standard therapy in advanced metastatic colorectal cancer (mCRC): A prospective cohort study compared with propensity score matching (PSM) cohortFuxiang Zhou, Wenbo Wang,Zhongnan Hospital of Wuhan University, Wuhan, China#3591Poster Session: Gastrointestinal Cancer —Colorectal and AnalEfficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective studyLu Xie, Binghao Li,Peking University People’s Hospital, Beijing, China; The Second Affiliated Hospital Zhejiang University, Hangzhou, China#11528Poster Session: SarcomaDisitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm studyHui Xu,Zhongnan Hospital of Wuhan University. Wuhan, China#e15003Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologySurufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II StudyDongsheng Zhang,Sun Yat-sen University Cancer Center, Guangzhou, China#e16297Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliarySurufatinib monotherapy or combined with vinorelbine as a late-line therapy in patients with refractory advanced non-small cell lung cancer (NSCLC)Yanfang Zheng,Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China#e20543Publication Only: Lung Cancer — Non-Small Cell MetastaticUpdated efficacy and safety results from the phase Ib/II study of surufatinib combined with camrelizumab and chemotherapy in patients with advanced colorectal cancerLiangjun Zhu, Sheng Li,Jiangsu Cancer Hospital, Nanjing, China#e15547Publication Only: Gastrointestinal Cancer — Colorectal and AnalPhase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysisXing Zhang,Sun Yat-sen University Cancer Center, Guangzhou, China#11539Poster Session: SarcomaEfficacy and safety of Surufatinib combined with EP regimen and Serplulimab in first-line treatment of NECTao Zhang, Zhenyu Lin,Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China#e15123Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologyPerformance of surufatinib in treating advanced neuroendocrine neoplasms: Insights from a real-world studyQing Zhai, Linhui Zhu,Fudan University Shanghai Cancer Center; Shanghai Medical College, Fudan University, Shanghai, China#e15124Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor BiologyEpidemiological investigation of neuroendocrine differentiation in carcinomas: Focus on pancreatic and cholangiocarcinoma cohortsSusheng Shi, Yaru Wen,Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China#e16375Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliaryEfficacy and safety of surufatinib, toripalimab, nab-paclitaxel in combination with radiotherapy or surgery in the first-line treatment of esophageal squamous cell cancer: A single-centered prospective clinical trialFang Liu, Xiang Huang,Chinese PLA General Hospital, Beijing, China#e16047Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and HepatobiliaryEfficacy and safety of second-line treatment with surufatinib for anlotinib-resistant radioiodine-refractory differentiated thyroid cancer: An exploratory multicenter studyLibo Chen, Yang Wang,Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China#e15127Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology 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 U.S. 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 but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and HMPL-295, the further clinical development for fruquintinib, surufatinib and HMPL-295, its expectations as to whether any studies on fruquintinib, surufatinib and HMPL-295, 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, surufatinib and HMPL-295, 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, surufatinib and HMPL-295 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin 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 Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500