Background on the Phase 2 Study of Ponatinib/Blinatumomab in Ph+ ALL


Fadi Haddad, MD, discusses the background of a phase 2 study of blinatumomab in combination with ponatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia.

Fadi Haddad, MD, a leukemia fellow at The University of Texas MD Anderson Cancer Center, discusses the background of a phase 2 study of blinatumomab (Blincyto®; Amgen) in combination with ponatinib (Iclusig®; Takeda) in Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

This chemotherapy-free regimen was designed as a result of the clinical activity shown with blinatumomab in relapsed/refractory ALL and the efficacy seen with ponatinib. Experts were hopeful that this option may offer patients higher chances of survival.

In the phase 2 study, 40 adult patients with newly diagnosed Ph+ ALL, 14 patients with relapsed/refractory Ph+ ALL, and 6 patients with chronic myeloid leukemia in lymphoid blast phase were treated with ponatinib plus blinatumomab.

Findings from the study were presented by Haddad during the Tenth Annual Meeting of the Society of Hematologic Oncology.


0:08 | Why [we presented] this study and why we believe this is important is because historically, the outcome of patients with Ph+ ALL has been poor with long-term survival around 10% to 15%. Throughout the years, the addition of tyrosine kinase inhibitors to chemotherapy significantly improved the survival of patients to up to 74% at 5 years with the combination of ponatinib and hyper-CVAD chemotherapy [cyclophosphamide, vincristine sulfate, doxorub icin hydrochloride, and dexamethasone].

0:41 | We realize that many patients are still relapsing despite optimal therapy. Plus, they were having major [adverse] effects from the chemotherapy itself, which we all know, that's why we were thinking, why don't we design a protocol that is chemotherapy-free, and that might offer patients higher chances of survival. That's how we designed our trial, which is the combination of blinatumomab, which is a bispecific CD19 and CD3 antibody which is converted to the traditional chemotherapy, it stimulates the immune system to go out and fight leukemia, in combination with a potent third generation tyrosine kinase inhibitor on ponatinib.

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