On September 7, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM, HKEX: 13) reported that new analyses and updates on the ongoing studies of amdizalisib (PI3Kδ inhibitor HMPL-689), savolitinib (ORPATHYS in China) and fruquintinib (ELUNATE in China) will be presented at the upcoming 2021 European Society for Medical Oncology ("ESMO") Virtual Congress taking place on September 16-21, 2021 (Press release, Hutchison China MediTech, SEP 7, 2021, View Source [SID1234590536]).
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AMDIZALISIB (also known as HMPL-689)
Title: A phase Ib study result of HMPL-689, a PI3Kδ inhibitor, in Chinese patients with relapsed/refractory lymphoma
Lead Author: Junning Cao, MD, Fudan University Shanghai Cancer Center
Session: Proffered Paper – Haematological Malignancies
Presentation Number: 833O
Date & Time: Monday, September 20, 2021 2:10 pm CEST
Location: Channel 3
SAVOLITINIB
Title: ORCHARD osimertinib + savolitinib interim analysis: A biomarker-directed phase II platform study in patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib
Lead Author: Helena Yu, MD, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Session: ePoster
Presentation Number: 1239P
Date available: Monday, September 13, 2021
FRUQUINTINIB
Title: An open-label, phase Ib/II study to evaluate the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced triple negative breast cancer
Lead Author: Debu Tripathy, MD, The University of Texas MD Anderson Cancer Center
Session: ePoster
Presentation Number: 337TiP
Date available: Monday, September 13, 2021
About Amdizalisib
Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s pharmacokinetics ("PK") properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.
HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In addition to the currently Phase II trial and the supportive Phase I trial in China, amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL).
HUTCHMED currently retains all rights to amdizalisib worldwide.
About Savolitinib (ORPATHYS in China)
Savolitinib is an oral, potent, and highly selective mesenchymal epithelial transition receptor (MET) tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.
Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.
In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib will be recognized by AstraZeneca.
About Fruquintinib (ELUNATE in China)
Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.