Surufatinib

BARCELONA — A new treatment option for a wide range of patients diagnosed with neuroendocrine tumors could be approved in April, as final results of a Phase 3 study on Exelixis’ cabozantinib were presented Monday at the ​​European Society for Medical Oncology. The CABINET study included two cohorts of people with neuroendocrine tumors depending on the tumor location — in the pancreas or outside of it. In 203 patients with extrapancreatic neuroendocrine tumors, cabozantinib lowered the risk of disease progression or death by 62% compared to placebo. In a smaller cohort of 95 patients with pancreatic tumors, Exelixis’ drug cut the risk of disease progression or death by 77%. The study had been stopped early at an interim analysis because of its compelling efficacy findings versus placebo. The trial investigators noted that the early termination of the study “could potentially lead to overestimation of the treatment effect,” though they added the progression-free survival analyses in both cohorts were “relatively mature,” according to a concurrent publication of the results in the New England Journal of Medicine . Exelixis markets cabozantinib as Cabometyx and Cometriq, and last year the company generated $1.8 billion in sales from the tyrosine kinase inhibitor. The drug is approved for kidney cancer, liver cancer and thyroid cancer, and is awaiting an FDA decision in neuroendocrine tumors by April 3 . Neuroendocrine tumors can occur anywhere in the body, meaning existing treatment options vary from patient to patient. Treatment options include somatostatin analogues like octreotide, everolimus, Novartis’ radiopharmaceutical Lutathera, chemotherapy, and the targeted therapy sunitinib — but what’s available to patients depends on their tumor. For example, Lutathera is approved for patients with a certain level of somatostatin receptor expression, while sunitinib is used in patients with pancreatic neuroendocrine tumors only. Gastrointestinal oncologist James Yao from the University of Texas MD Anderson Cancer Center told Endpoints News on the sidelines of the confab that for lung neuroendocrine tumor patients, this approval could be especially impactful because the only current go-to option for them is everolimus. Patients were enrolled in Exelixis’ study regardless of where their primary tumor was, though they were required to have tried at least one previous therapy. The median number of previous treatments was two or three across the study cohorts. “We were looking at a very broad group of patients … and we saw efficacy across the board,” Dana-Farber Cancer Institute neuroendocrine tumor specialist Jennifer Chan said. “This opens up options for a large number of patients. It’s not limited to just a small subset of patients.” Chan, the principal investigator on the study, spoke to Endpoints ahead of her Monday presentation. Yao noted that in China, the tyrosine kinase inhibitor surufatinib is approved for both pancreatic and extrapancreatic neuroendocrine tumors. The drug, developed by Hutchmed, was rejected in the US by the FDA in 2022 as its pivotal clinical trials were run in China. In Exelixis’ Phase 3 study, the median progression-free survival was 8.4 months on cabozantinib compared to 3.9 months on placebo in extrapancreatic tumors. In pancreatic neuroendocrine tumors, the median progression-free survival was 13.8 months compared to 4.4 months for placebo, with p<0.001 in both groups. Also, the response rate was 5% and 19% in extrapancreatic and pancreatic neuroendocrine tumors, respectively, versus 0% with placebo. The most common severe treatment-related adverse events were hypertension, fatigue, diarrhea, and thromboembolic events. Around two-thirds of patients in both the extrapancreatic and pancreatic groups on cabozantinib required dose reductions of the drug, and 31% and 20% of patients in the respective groups discontinued treatment due to adverse events. Exelixis’ medical chief Amy Peterson said that because cabozantinib is already approved in liver cancer, gastrointestinal oncologists are already familiar with the drug. They’re also familiar with the toxicities and dose reductions needed for sunitinib, which is also a VEGF tyrosine kinase inhibitor. In August, Exelixis announced that Cabometyx in combination with Tecentriq did not improve survival in a pivotal prostate cancer trial called CONTACT-02, details of which were shared at ESMO as well. Exelixis’ partner Ipsen, which has rights to Cabometyx outside of the US and Japan, announced Sunday that it does not plan to seek regulatory approvals based on the study. Exelixis confirmed to Endpoints that it still plans to file for approval based on the prostate cancer study this year.

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 09, 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 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 detailsWCLC24 - INVESTIGATOR-INITIATED STUDIES Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm advanced NSCLC (CTONG 2008): A Phase II trialJinji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Southern Medical University, Guangzhou, ChinaPL04.10Plenary Session PL04 Presidential Symposium 2, Plenary HallMonday, September 9, 2024 at 8:30 AM PDTStudy 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.04AePosterSaturday, September 7, 2024Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Non-Squamous NSCLC: A Phase Ib/II Study Qitao Yu, Wei Jiang, Guangxi Medical University Cancer Hospital, Nanning, ChinaP3.12C.08PosterMonday, 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 detailsESMO 2024 - SPONSORED STUDIESEfficacy 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 cancerMonday, 16 September 2024Efficacy 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, Spain526PPoster Session – Colorectal cancerMonday, 16 September 2024Efficacy 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, China1410PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Impact 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 studyRuihua Xu,Sun Yat-sen University Cancer Center, Guangzhou, China1434PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Association 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, China1443PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Analysis 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, China1461PPoster Session – Oesophagogastric cancerMonday, 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, China570PPoster Session – Colorectal cancerMonday, 16 September 2024Stereotactic 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 cancerMonday, 16 September 2024Fruquintinib 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 Ma,Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing, China1329P Poster Session – NSCLC, metastaticSaturday, 14 September 2024Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)Xiaobing Chen, Beibei Chen,Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China1475TiPPoster Session – Oesophagogastric cancerMonday, 16 September 2024Fruquintinib 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 cancerMonday, 16 September 2024A 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, China1743PPoster Session – SarcomaSaturday, 14 September 2024Surufatinib 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, China974PPoster Session – Hepatocellular carcinoma (HCC)Monday, 16 September 2024Updated 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, China1155PPoster Session – Neuroendocrine tumoursMonday, 16 September 2024Surufatinib 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, Wenfeng Fang,Sun Yat-Sen University Cancer Center, Guangzhou, China1345PPoster Session – NSCLC, metastaticSaturday, 14 September 2024Surufatinib 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, China1740PPoster Session – SarcomaSaturday, 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 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, 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 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 /Rupert Dearden, Panmure Liberum+44 (20) 7886 2500