ASH 2022 | Investigating the efficacy of ponatinib and blinatumomab for patients with newly diagnosed Ph+ ALL
Nicholas Short, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, describes and outlines findings from a Phase II study investigating the efficacy of ponatinib and blinatumomab for patients with newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). After five cycles of the regimen, it was found that the treatment was well-tolerated and highly effective, with many patients achieving complete molecular response and measurable residual disease (MRD) negativity. With very encouraging results, Dr Short believes that this novel regimen could become a new standard of care for Ph+ ALL. This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA.
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Transcript (edited for clarity)
Sure. So I’ll be presenting data from our ongoing study of the chemotherapy-free combination of ponatinib and blinatumomab for patients with newly diagnosed Philadelphia chromosome-positive ALL. So as background, we know that intensive chemotherapy plus a tyrosine kinase inhibitor has been considered standard of care for patients with Philadelphia chromosome-positive ALL, generally followed by a subsequent allogeneic stem cell transplant...
Sure. So I’ll be presenting data from our ongoing study of the chemotherapy-free combination of ponatinib and blinatumomab for patients with newly diagnosed Philadelphia chromosome-positive ALL. So as background, we know that intensive chemotherapy plus a tyrosine kinase inhibitor has been considered standard of care for patients with Philadelphia chromosome-positive ALL, generally followed by a subsequent allogeneic stem cell transplant. We’ve shown very encouraging data with hyper-CVAD + ponatinib, which is a very potent TKI in this setting, with five-year survival rate around 75%. Blinatumomab is also very effective in the relapsed refractory setting and concluding in Ph+ ALL, and there’s encouraging data with dasatinib and blinatumomab as a chemotherapy-free regimen in this setting with a four-year survival of 78%.
So the goal of this study was to evaluate a more potent TKI ponatinib in combination with blinatumomab to see if we can further improve on those outcomes. So the study design is we give five cycles of the combination of ponatinib and blinatumomab, and then we give maintenance ponatinib for at least five years. We’ve treated 40 patients to date, 96% of patients have achieved a response, 87% achieved a complete molecular response, and 88% achieved MRD negativity by a highly sensitive next-generation sequencing assay. To date, we’ve only transplanted one of those patients, we’ve only seen two relapses so far, and the estimated two-year event-free survival is 93%, and the two-year overall survival is 95%. So these compare very favorably with historical data in Philadelphia chromosome-positive ALL. This seems to represent a truly chemotherapy-free regimen for these patients, and also one where I think we can avoid transplant in the vast majority of patients.
And I think with longer term follow up, we’ll see this becoming hopefully a new standard of care. And I would say that these kind of studies have really revolutionized the treatment of Ph+ ALL, where this used to be one of the most aggressive forms of leukemia that we had and now it’s one of the most treatable and I hope now curable.
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Disclosures
Novartis: Consultancy; Astellas: Research Funding; Takeda Oncology: Consultancy, Research Funding; Pfizer: Consultancy; Stemline Therapeutics: Research Funding; AstraZeneca: Consultancy; Amgen: Consultancy, Honoraria.
