On March 31, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors ("FGFR"), in patients with advanced malignant mesothelioma (Press release, Hutchison China MediTech, MAR 31, 2020, https://www.chi-med.com/chi-med-initiates-a-phase-ii-trial-of-hmpl-453-in-patients-with-advanced-malignant-mesothelioma-in-china/ [SID1234556026]).
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The clinical study is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in historically confirmed patients with advanced malignant mesothelioma that failed at least one line of systemic therapy.
The primary outcome measure is overall response rate (ORR). Secondary outcome measures include preliminary efficacy such as disease control rate (DCR), time to response (TTR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS). The lead investigator of the study is Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University. Additional details may be found at clinicaltrials.gov, using identifier NCT04290325.
About Fibroblast Growth Factor Receptors (FGFR)
FGFRs are a sub‑family of receptor tyrosine kinases. Activation of FGFR signaling pathways is central to several biological processes. In normal physiology, FGF/FGFR signaling is involved in embryonic development (organogenesis and morphogenesis), tissue repair, angiogenesis, neuroendocrine and metabolism homeostasis. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, as well as conferring resistance to anti‑tumor therapies.
About HMPL‑453
HMPL‑453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptors 1, 2 and 3. In pre‑clinical studies, HMPL‑453 demonstrated superior potency and better kinase selectivity as compared to other drugs in the same class, as well as a favorable safety profile. Enrollment has been completed for the dose escalation of the Phase I study of HMPL-453 in China, for which additional details can be found at clinicaltrials.gov, using identifier NCT03160833.