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Takeda to Discuss Positive Phase III Iclusig Data in Upfront ALL With Regulators

NEW YORK – Takeda said on Thursday that it plans to meet with regulatory agencies to discuss positive data from its Phase III PhALLCON clinical trial of Iclusig (ponatinib) as treatment for certain acute lymphoblastic leukemia patients.

The randomized PhALLCON trial compared Iclusig versus Novartis' Gleevec (imatinib) when both are combined with reduced intensity chemotherapy as a first-line treatment among 230 adults with Philadelphia chromosome-positive acute lymphoblastic leukemia.

Takeda said on Thursday that the trial met its primary endpoint by showing that the Iclusig-based regimen improved rates of minimal residual disease negativity compared to the Gleevec-based regimen. The firm hasn't yet released any data from the trial but said it will do so going forward. According to Takeda, PhALLCON is the first global, Phase III head-to-head comparison of two TKIs in the frontline treatment setting for Philadelphia chromosome-positive ALL.

The third-generation tyrosine kinase inhibitor Iclusig is designed to target BCR-ABL1 mutations and treatment-resistant mutations such as T315I. The drug already has US Food and Drug Administration approval for treatment-resistant chronic-phase chronic myeloid leukemia, accelerated-phase or blast-phase CML; for Philadelphia chromosome-positive ALL patients with no other kinase inhibitor treatment options; and for T315I-positive CML or T315I-positive Philadelphia chromosome-positive ALL.