Takeda's Iclusig delivers a win in rare subtype of acute lymphoblastic leukemia

Takeda picked up Iclusig as part of a $5.2 billion deal with Ariad with the promise that it could make some more out of the blood cancer drug. So far, so good.

On Thursday, the Japanese company reported that a phase 3 trial of Iclusig plus reduced-intensity chemotherapy performed better than Novartis’ chemotherapy Gleevec in patients with newly-diagnosed Philadelphia-chromosome-positive acute lymphoblastic leukemia (Ph+ALL).

The disorder is a subtype of the common childhood cancer ALL. There are no targeted treatments approved for frontline Ph+ALL in the United States.

Takeda didn’t break down the results of the PhALLCON trial, only to say that it met its primary endpoint. In the study, patients achieved higher rates of minimal residual disease (MRD) negative complete remission on Iclusig than on Gleevec.

“There is an urgent need for an effective treatment that can suppress the development of difficult-to-treat mutations, which are associated with poor long-term outcomes,” Awny Farajallah, M.D., Takeda’s head of global medical affairs oncology, said in a release. 

Takeda looks forward to sharing the results with regulators, Farajallah added.

Iclusig is a tyrosine kinase inhibitor (TKI) that targets BCR-ABL1, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Ph+ALL. In 2020, Iclusig won FDA approval to treat CML. Iclusig’s first endorsement—for two rare types of leukemia—came when it was owned by Ariad in 2012.

The PhALLCON trial was the first of its kind comparing two TKIs in frontline Ph+ALL, Takeda said. The condition affects roughly 25% of adult ALL patients in the U.S. and is characterized by the presence of the abnormal Philadelphia chromosome, which leads to the development of BCR-ABL1.