Clinical studies of ensidipine

Celgene Corporation and Agios Pharmaceuticals conducted a Phase I clinical study of enasidenib enrolling 239 patients with advanced hematologic malignancies and IDH2 mutations. A total of 176 patients developed relapsed/refractory (R/R) acute myeloid leukemia (AML). In the dose escalation group, patients received R/R treatment at 50 mg to 650 mg daily.

The results of the study showed that relapsed/refractory patients who received treatment achieved the primary endpoint, with an overall response rate of 40.3% and a complete response rate of 19.3%. The U.S. Food and Drug Administration (FDA)approval of ensidipine was based on the results of an open-label, single-arm, multicenter, dual-cohort clinical trial. The study enrolled 199 adult patients with R/R AML and an Abbott RealTime-confirmed IDH2 mutation for IDH2 testing. Ensidipine was administered orally at a starting dose of 100 mg daily until disease progression or unacceptable toxicity.

Study results showed that patients treated with ensidipine showed a complete response (CR) or complete remission, with a partial hematological improvement (CRh) rate of 23%. The median duration of CR/CRh was 8.2 months. The study also showed that 53 of 157 patients who were red blood cell (RBC) and platelet transfusion dependent at baseline became independent during any 56 days after baseline. Of the 42 patients who were red blood cell and platelet transfusion independent at baseline, 32 became transfusion independent within 56 days of baseline.

The safety of ensidipine was evaluated in patients with relapsed/refractory (R/R) acute myeloid leukemia and IDH2 mutations. During clinical studies, the most common adverse reactions noted in patients receiving ensidipine were nausea, vomiting, diarrhea, increased bilirubin, and decreased appetite.

Encidipine research medicine is not currently on the market in China, so it cannot be included in 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 ensidipine drugs produced by other pharmaceutical companies overseas. For example, the price of Specification50mg*30 tablets produced by a Laos pharmaceutical factory may be more than 2,000 yuan per box (the price may fluctuate due to the exchange rate). Its pharmaceutical ingredients are basically the same as those of the original drugs sold abroad. For more information on overseas drug prices and specific information, please consult Yaode Medical Consultant.