Ibrutinib May Be Safe, Effective for Chronic Lymphocytic Leukemia with TP53 Aberrations

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According to a new study published in the journal The Lancet Oncology, ibrutinib alone may be safe and effective for the first- or second-line treatment of patients with high-risk chronic lymphocytic leukemia (CLL) with TP53 aberrations.

For this single-arm, phase 2 study, researchers at the National Institutes of Health Clinical Center in Bethesda, Maryland, enrolled 47 patients with active CLL with deletion 17p13.1 and four patients with a TP53 aberration without a 17p13.1 deletion. Of those, 35 had previously untreated disease while 16 had relapsed or refractory CLL.

All patients received ibrutinib 420mg orally once daily in 28-day cycles until disease progression or unacceptable toxicity. Results showed that among the 33 evaluable previously untreated patients at 24 weeks, 97% (95% CI: 86-100) achieved an objective response. One patient had progressive disease.

Among the 15 evaluable patients with relapsed or refractory disease, 80% (95% CI: 52-96) achieved an objective response. In regard to safety, 24% of patients experienced severe neutropenia, 14% had severe anemia, and 10% experienced severe thrombocytopenia. Six percent of patients experienced grade 3 pneumonia and 2% had grade 3 rash.

The findings suggest that ibrutinib alone should be considered as an option for patients with high-risk CLL with TP53 aberrations for first- or second-line treatment.

Multiple myeloma treated with SAR650984 in combination with lenalidomide/dexamethasone see clinical
Ibrutinib alone may be safe and effective for the first- or second-line treatment of CLL with TP53 aberrations.
The authors investigated the safety and activity of ibrutinib in previously untreated and relapsed or refractory CLL with TP53 aberrations. The activity and safety profile of single-agent ibrutinib in CLL with TP53 aberrations is encouraging and supports its consideration as a novel treatment option for patients with this high-risk disease in both first-line and second-line settings.

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