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Chi-Med Initiates a Phase I Trial of HMPL-523 in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia in China
Oct. 18, 2018 08:46AM PST
Pharmaceutical InvestingHutchison China MediTech (AIM/Nasdaq:HCM) has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase inhibitor, in combination with azacitidine, an approved nucleoside metabolic inhibitor, in elderly patients with acute myeloid leukemia in China. As quoted in the press release: This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, …
Hutchison China MediTech (AIM/Nasdaq:HCM) has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase inhibitor, in combination with azacitidine, an approved nucleoside metabolic inhibitor, in elderly patients with acute myeloid leukemia in China.
As quoted in the press release:
This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of the combination in previously untreated elderly patients with AML who are not eligible for standard induction therapy. The primary outcome measures are overall response rate (ORR) and adverse events (AE). The two-stage study will have a dose escalation and dose expansion stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03483948.
This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in a broad range of hematological cancers in Australia (clinicaltrials.gov identifier: NCT02503033) and China (clinicaltrials.gov identifier: NCT02857998). These include chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma and Waldenstrom’s macroglobulinemia. Chi-Med targets to present dose escalation results at a major scientific conference later in 2018 or in 2019.