ASCO: Takeda's Iclusig shows potential to become standard of care in acute lymphoblastic leukemia subtype

In November, Takeda said its blood cancer drug Iclusig topped Novartis’ Gleevec in a phase 3 trial in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).

Just one problem: The Japanese company didn’t put any numbers to its claim.

Three months later, at the American Society of Clinical Oncology virtual conference, Takeda finally got to the big reveal. The company is touting data indicating Iclusig has the potential to become the “standard of care” in the indication, according to the abstract’s lead author, Elias Jabbour, M.D., of the University of Texas MD Anderson Cancer Center.

The PhALLCON trial was the first head-to-head comparison in first-line treatment with Iclusig (ponatinib), a third-generation tyrosine kinase inhibitor, squaring off against Gleevec (imatinib), a first-generation TKI.

The study included 245 patients randomized 2:1 to receive Iclusig or Gleevec plus reduced-intensity chemotherapy. In the primary endpoint, which measured how many patients had no detectable amount of disease or any signs or symptoms of cancer after a 12-week induction period, Iclusig topped Gleevec 34.4% to 16.7%.

“The potential benefit to patients who achieve this early deep response may be important to improve long-term survival outcomes,” Jabbour observed in the abstract.

In the Iclusig group, 7% of patients discontinued treatment because of lack of efficacy compared with 26% in the Gleevec group. Both treatment groups had a 12% rate of discontinuation for side effects. 

Iclusig was developed by Ariad and gained approval in 2012. Five years later, Takeda picked up the cancer specialist for $5.2 billion. In 2020, the FDA expanded Iclusig’s label in chronic myeloid leukemia.

Now another expansion could be coming in Ph+ALL. It would be an import development in a disease in which patients often build up resistance to first-generation TKIs.

“Future research comparing ponatinib to a second generation TKI would help determine the best choice of TKI for these patients,” Olatoyosi Odenike, M.D., ASCO’s expert in leukemia, said in the abstract. "Chemotherapy-free regimens incorporating TKIs in combination with antibody-based therapies are actively being investigated in this disease.”