Posted by on Apr 12, 2020 in Leukemia | 0 comments

In a nutshell

This study aimed to investigate the long-term safety and effectiveness of ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. 

This study concluded that ibrutinib was safe and effective in the long-term in this group.   

Some background

Ibrutinib (Imbruvica) is a type of targeted therapy called a tyrosine kinase inhibitor (TKI) used in treatment of B cell cancers such as chronic lymphocytic leukemia (CLL). It has shown very good results in short-term studies. However, the long-term safety and effectiveness of ibrutinib in patients with CLL or small lymphocytic leukemia (SLL) remain under investigation. 

Methods & findings

This study involved 132 patients with first-time or relapsed/refractory CLL or SLL. All patients were treated with ibrutinib. Patients were followed for an average of 8 years.  

The overall response rate (ORR) was 89%. The ORR for the first-line group was 87% and 89% in the relapsed/refractory group. The complete response (CR) was 35% for the first-line group and 10% in the relapsed/refractory group.  

The estimated 7-year progression-free survival (PFS) rate was 83% in the first-line group and 34% in the relapsed/refractory group. The average PFS was not reached with first-line ibrutinib. In the relapsed/refractory group, the median PFS was 52 months overall.  

The estimated 7-year overall survival (OS) rate was 84% in the first-line group and 55% in relapsed/refractory group. 

28% of patients had hypertension (high blood pressure) as a serious side effect. 24% of patients had serious pneumonia and 18% of patients had serious neutropenia (low-level white blood cells). Side effects leading to ending treatment were only observed in the relapsed/refractory group. 

The bottom line

This study concluded that ibrutinib was safe and effective in the long-term in patients with first-line or relapsed/refractory CLL or SLL.  

The fine print

This study had a small number of participants. The study was funded by Pharmacyclics LLC, the manufacturer of ibrutinib.

Published By :

Clinical Cancer Research

Date :

Mar 24, 2020

Original Title :

Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase 1b/2 PCYC-1102 Study.

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