NEWS

News Class 1 or another ABL001 Praise Phase 3 clinic triple in China.

Release time:

2021-11-19 14:31

Chronic myeloid leukemia (CML)It is a myeloid proliferative tumor derived from pluripotent stem cells, which is characterized by a significant increase in granulocytes in the peripheral blood, resulting in anemia, bleeding, and multiple organ infection.CMLThe incidence rate in China is (0.39～0.99)/10million, the median age of onset is45～50The disease develops slowly,CanIt is divided into chronic phase, accelerated phase and acute phase.and in partCMLpatients, the Philadelphia chromosome can be found and/orBCR-ABLFusion genes.

AlthoughThere are a variety of tyrosine kinase inhibitors (TAKES) can be used to treatCMLHowever, for patients with recurrence of the disease, there may be a subsequentTAKESThe problem of resistance or intolerance to therapyTherefore, it is necessaryCMLPatients looking for a new treatment option.

Early in10At the end of the month,FDAApprovedNovartis(Novartis)1class of new drugsABL001(Asciminib)marketed for the treatment of Philadelphia chromosome-positive in chronic stageCMLpatients, who had previously received more than twoTAKESThe treatment.

As11Month15Novartis also launched the China Drug Clinical Trials Registration and Information Publicity Platform on Sunday.ABL001Treatment of newly diagnosed Philadelphia (Ph) Chromosome positiveCMLadult patients in chronic phaseof3phase clinical.

public information shows that,ABL001is a paragraphABL1Allosteric inhibitors.The allosteric effect refers to the effect that a protein changes its structure by binding to a ligand or other protein, thereby changing its physiological function. Among the various ways of regulating protein conformation, allosteric effects are direct, rapid and effective.

specifically,ABL001The mechanism of action is to mimic the regulation of proteins in nature by increasing the lipid chain tail (myristic acid). under normal circumstancesABL1myristoylationN-end, occupying an empty pocket in the kinase domain;ABL001BywithABL1The myristoyl pocket (myristoyl pocket) binding, thereby inhibitingBCR-ABL1of activity.ABL001It plays the role of allosteric inhibition. This unique mechanism of action and the traditionalTAKESDifferent, therefore, to the traditionalTAKESDrug-resistant tumors also have potent inhibitory activity.

Novartis launched in China this time3phase clinical trial, a randomized, open, parallel-group, international multicenterClinical Trials, testThe results show that compared with the active control,ABL001In24Weeks almost made the patient's main molecular response rate (MMR) doubled (25.5% vs 13.2%). In addition, in terms of the proportion of patients who discontinue treatment due to adverse reactions,ABL001The treatment group was the 1/3 of the control group (7% vs 25%）。

ExpectABL001in china's3PeriodThe clinical study was carried out smoothly and achieved good results as soon as possible.CMLpatients with new treatment options.

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