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Ponatinib plus chemotherapy and allo-HSCT in newly diagnosed Ph+ ALL: Final results from the PONALFIL trial
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The phase II PONALFIL trial (NCT02776605) from the Programa Español de Tratamientos en Hematología (PETHEMA) group assessed the safety and efficacy of ponatinib in combination with standard induction and consolidation chemotherapy followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) with pre-emptive ponatinib after allo-HSCT in 30 adult patients with newly diagnosed (ND) Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL).1 The ALL Hub previously reported the initial results from this trial. Below, we summarize the final results from this trial, with a median follow-up of 4 years, presented by Ribera during the European Hematology Association (EHA) 2024 Hybrid Congress.1
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| Key learnings |
| The complete molecular response rates post-induction (n = 30), post-consolidation (n = 28), and post-allo-HSCT (n = 26) were 47%, 71%, and 100%, respectively. |
| The 4-year overall survival (OS) and event-free survival rates were 92% and 66%, respectively, with no differences according to BCR-ABL1 isoform. |
| Overall, six patients relapsed after the transplant and were successfully managed with ponatinib, chemotherapy, and CAR T-cell therapy or a second allo-HSCT. |
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A propensity-score comparison between the PONALFIL trial and the PhALL08 trial (NCT01491763), which used imatinib, showed that the PONALFIL cohort had:
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| These final results from the PONALFIL trial confirm the efficacy of ponatinib in combination with standard induction and consolidation chemotherapy followed by allo-HSCT and further support the use of this regimen as a first-line therapy for adult patients with newly diagnosed Ph+ ALL. |
- Ribera JM. Ponatinib, chemotherapy and transplantation for newly diagnosed adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Final results of the phase 2 PONALFIL trial. Poster #P398. Presented at: European Hematology Association 2024 Hybrid Congress; Jun 13–16, 2024; Madrid, ES.
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