In a nutshell
This study aimed to investigate if acalabrutinib (Calquence) was safe and effective as a treatment for patients with relapsed or refractory chronic lymphocytic leukemia. This study concluded that acalabrutinib was safe and effective in these patients.
Acalabrutinib is commonly used as a second-line treatment for non-Hodgkin lymphoma. It is a type of targeted therapy called a Bruton tyrosine kinase inhibitor (bTKI). TKIs work to block signals that make cancer cells grow and divide.
It was unknown if acalabrutinib was safe and effective for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).
Methods & findings
This study involved 310 adult patients with R/R CLL. 155 patients received acalabrutinib treatment. The other patients received other standard treatments for R/R CLL: 119 received idelalisib (Zydelig) plus rituximab (Rituxan) or IR and 36 received bendamustine (Treanda) plus rituximab or BR. Most patients had received an average of two prior treatments. Patients were followed for an average of 16.1 months.
The average survival without cancer getting worse for the acalabrutinib group was not reached (was higher) at the end of 16.1 months and was 16.5 months for the IR and BR group together. The estimated 12-month survival rate without cancer getting worse was 88% for the acalabrutinib group compared to 68% for the IR and BR group. Acalabrutinib prolonged survival without cancer worsening by 69% compared to standard therapy.
Serious side effects occurred in 29% of the acalabrutinib group compared to 56% of the IR group and 26% of the BR group. The most common side effects were headaches in the acalabrutinib group, diarrhea and low white blood cell counts in the IR group, and low white blood cell counts, fatigue, nausea, and inclusion-related reactions in the BR group.
The bottom line
This study concluded that acalabrutinib significantly improved survival without cancer getting worse when compared to IR or BR and had an acceptable safety profile in patients with R/R CLL.
The fine print
This study received funding support from AstraZeneca, the manufacturer of acalabrutinib.
Published By :
Journal of clinical oncology
May 27, 2020