Novartis leukemia therapy starts phase 3 clinical trial in China and just got approval in the US

TextPharmaceutical Guanlan

On November 15, the China Drug Clinical Trial Registration and Information Publicity Platform revealed that Novartis has initiated Phase 3 treatment of ABL001 in newly diagnosed Philadelphia (Ph) chromosome-positive chronic myeloid leukemia (CML) adult patients in the chronic phase in China.

Screenshot source: Drug Clinical Trial Registration and Information Publicity Platform

CML is a malignant myeloproliferative neoplasm that occurs in pluripotent hematopoietic stem cells and is characterized by a marked increase in peripheral blood granulocytes

ABL001 is an allosteric inhibitor against ABL1, which inhibits the activity of BCR-ABL1 by binding to the myristoyl pocket of ABL1

▲The mechanism of action of ABL001 (asciminib) (Image source: Reference [2])

At the end of October 2021, the FDA accelerated the approval of ABL001 for the treatment of patients with Philadelphia chromosome-positive CML in the chronic stage who have been previously treated with more than two TKIs

Phase 3 clinical trial results showed that ABL001 nearly doubled the patient's major molecular response rate (MMR) at 24 weeks (25.

In July this year, ABL001 was approved for clinical research in China

It is hoped that the clinical study of ABL001 in China will also proceed smoothly and achieve good results, bringing new treatment options to patients as soon as possible

References:

[1] Official website of Center for Drug Evaluation, State Food and Drug Administration of China.

[3] Hughes, et al.