The role and efficacy of Enasidenib

Enasidenib (Enasidenib) (originalAG-221) is an oral small molecule selective inhibitor of mutantIDH2 enzyme. Preclinical studies have shown that ensidipine can effectively inhibit the production of high-potency 2-hydroxyglutarate and alleviate the differentiation block induced by mutant IDH2.

In the initial Phase I/II trial of AG221-001, patients with relapsed or refractory (R/R) IDH2-mutant acute myeloid leukemia received ensidipine monotherapy with dose escalation to 650 mg daily, with the 100 mg dose level determined to be safe and effective and available for further evaluation. Overall, 113 patients received dose-escalation therapy and 126 patients received dose-expansion therapy. The overall response rate for R/R patients was 40%, including 19% complete responses. At a median follow-up of 7.7 months, median overall survival was 9.3 months and 19.7 months among responders. Although adverse events of clinical concern include indirect hyperbilirubinemia and IDH inhibitor-induced differentiation syndrome, which can be life-threatening if not recognized and treated promptly, ensidipine was well tolerated.

Ensiidi plain investigational medicine is not currently on the market in the country, nor is it covered by medical insurance. The price of ensidipine plain medicine when it is launched overseas is very high, and the price of each box may be around 30,000 yuan (the price may fluctuate due to the exchange rate). Currently, there are cheaper generic encidipine drugs produced by other pharmaceutical companies overseas. For example, the price of Specification50mg*60 tablets produced by a Bangladesh pharmaceutical factory may be around 4,000 yuan per box (the price may fluctuate due to exchange rates). Its drug ingredients are basically the same as those of the original encidipine generic drug.