On October 16, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that new and updated clinical data from several ongoing studies of fruquintinib, in combination with chemotherapies and/or immunotherapies, will be presented at the upcoming European Society for Medical Oncology ("ESMO") Congress 2023, taking place on October 20-24, 2023 in Madrid, Spain (Press release, Hutchison China MediTech, OCT 16, 2023, View Source [SID1234636000]).

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Details of the presentations are as follows:

Abstract title

Presenter / Lead author

Presentation details

SPONSORED STUDY

Fruquintinib plus Sintilimab in patients with either treatment naïve or previously treated advanced gastric or gastroesophageal junction adenocarcinoma: results from a multicenter, single-arm phase Ib/II study

Xiaoli Wei, Harbin Medical University Cancer Hospital, Harbin, China

1519P
Poster presentation (Oesophagogastric cancer)
Monday, October 23, 2023

INVESTIGATOR-INITIATED STUDIES

First report of the safety/tolerability and preliminary antitumor activity of fruquintinib plus capecitabine versus capecitabine as maintenance treatment for metastatic colorectal cancer: an open-label, randomized phase Ib/II study

Wenhua Li, Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China

639P
Poster presentation (Colorectal cancer)
Sunday, October 22, 2023

Updated results from the multicenter phase II study of fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal cancer (mCRC)

Fuxiang Zhou, Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China

612P
Poster presentation (Colorectal cancer)
Sunday, October 22, 2023

A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic artery infusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases (CRLM)

Lu Wang, Liver surgery department, Fudan University Shanghai Cancer Center, Shanghai, China

637P
Poster presentation (Colorectal cancer)
Sunday, October 22, 2023

Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naive EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a phase II trial

Pei Ma, Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

1494P
Poster presentation (NSCLC, metastatic)
Monday, October 23, 2023

About Fruquintinib

Fruquintinib is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has been shown to be generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE. A marketing submission to the U.S. Food and Drug Administration ("FDA") was granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. In addition, a submission to the European Medicines Agency ("EMA") was validated and accepted for review in June 2023, and a submission to the Japan Pharmaceuticals and Medical Devices Agency ("PMDA") took place in September 2023.

Takeda has the exclusive worldwide license to further develop, and commercialize, and manufacture fruquintinib outside of China. Fruquintinib is developed and marketed in China by HUTCHMED, in partnership with Eli Lilly and Company.