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EHA 2021 | Outcomes of TP53-disrupted CLL patients treated with frontline ibrutinib

Andrea Visentin, MD, PhD, University of Padua, Padova, Italy, talks on the findings of a real-world study of the outcomes of TP53-disrupted chronic lymphocytic leukemia (CLL). The aim of the study, which analysed data from 100 patients with CLL, was to describe the efficacy and discontinuation rate of ibrutinib in patients with treatment-native CLL. The study reported an overall response rate of 84%. 28 patients discontinued treatment, of which 20 discontinued due to adverse events, including eight infections, five atrial fibrillations and three deaths. Dr Visentin gives an overview of the study’s findings and comments on the implications of this data. This interview took place at the virtual European Hematology Association (EHA) Congress 2021.

Transcript (edited for clarity)

We know that the TP53 disruption including 17p deletion and the TP53 gene mutation is a negative prognostic biomarker in chronic lymphocytic leukemia. Associated with genome complexity or the relapse and shorter survival after chemoimmunotherapy. Ibrutinib is the first in-class BTK inhibitor and has proven to be highly active in CLL patient with unfavorable clinical features. However, data from the real-life setting in treatment, the patient, with TP53 disruption derived from almost 90 patients, including five clinical trials...

We know that the TP53 disruption including 17p deletion and the TP53 gene mutation is a negative prognostic biomarker in chronic lymphocytic leukemia. Associated with genome complexity or the relapse and shorter survival after chemoimmunotherapy. Ibrutinib is the first in-class BTK inhibitor and has proven to be highly active in CLL patient with unfavorable clinical features. However, data from the real-life setting in treatment, the patient, with TP53 disruption derived from almost 90 patients, including five clinical trials. So, data from the real-life setting are quite scanty.

We performed a retrospective study, recruiting for these centers, belonging to Italian CLL Campus network. We enrolled a hundred patients with CLL. We did frontline with ibrutinib. All of them have TP53 disruption and after a median follow-up of 24 months, the overall response rate was 80%, including 9% in patient with complete remission of the disease, as confirmed by bone marrow biopsies, and the 24 months median PFS time to next treatment and overall survival were not reached. In particular, the 24-month PFS time to next treatment and overall survival where 82%, 89% and 92%, respectively.

We observe that the PFS was shorter in patients with at least 75 years old and in patient with both deletion and mutation rather than patient with only 17p or only TP53 mutation. And of course, patient who responded to treatment reaching at least partial remission, have a longer progression-free survival, while [inaudible] stage and IGHV mutation status did not impact in PFS.

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Disclosures

Andrea Visentin, MD, PhD, has participated in consultancy work for Gilead, Italffarmaco, Janssen, and Takeda; is a member of the scientific boards of Janssen, Abbvie, CLS Behring; and has participated in speaker’s bureaus for Janssen, Abbvie, AstraZeneca.

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