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Patients with chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ALL) who are resistant to or intolerant of second-generation tyrosine kinase inhibitors (TKIs) have had limited treatment options. Now, investigators have conducted an industry-sponsored, phase II, multinational, open-label trial (PACE) of the novel TKI ponatinib (45 mg orally once daily) for 449 CML and Ph+ALL patients previously treated with nilotinib, dasatinib, or both.
Major cytogenetic response (MCR, the primary endpoint) was achieved in 56% of chronic-phase CML patients, including 34% with major molecular response. Impressively, 70% of patients with the BCR-ABL T315I mutation, which is commonly observed in patients resista…