Study: Imbruvica for CLL Is Less Likely to Lead to Next-Line Treatment Than Acalabrutinib


Results show possible impact of using Janssen Pharmaceuticals’ ibrutinib in the front-line setting, providing additional data on chronic lymphocytic leukemia therapies.

Individuals with chronic lymphocytic leukemia (CLL) who were treated with first-line acalabrutinib (Calquence; AstraZeneca) monotherapy were 89% more likely to start a next-line treatment than those treated with ibrutinib (Imbruvica; Janssen Pharmaceuticals), according to the results of a real-world study presented as an oral presentation during the 2022 American Society of Hematology Annual Meeting.

The results suggest that the potential of first-line treatment with ibrutinib may provide individuals with the ability to use a once-daily, oral treatment option as a monotherapy for a longer period without the need to start the next line of treatment.

“There are currently no comparative clinical trials in first-line CLL among the BTK [inhibitors] class, highlighting the critical need to leverage real-world experience to support optimized treatment selection,” Ryan Jacobs, MD, clinical director of Division of Lymphoma Therapy & Research in the Department of Hematologic Oncology at Atrium Health Levine Cancer Institute, said in a statement. “These results demonstrate the possible impact of using ibrutinib versus acalabrutinib in the front-line setting and provide healthcare professionals with additional data showing differences in time to next treatment.”

Investigators used de-identified academic electronic medical records to identify individuals initiating first-line treatment with acalabrutinib or ibrutinib between November 21, 2019, and April 30, 2022. They examined time to next treatment (TTNT) as a clinically meaningful surrogate measure for disease progression. TTNT was defined as the time from the index date to the initiation of an additional or next treatment.

Among treatment-naïve individuals with CLL or small lymphocytic leukemia, individuals treated with acalabrutinib in the first line were more likely to start a new treatment compared with taking first line ibrutinib

Investigators also found that a similar result was observed when censoring anti-CD20 add-on therapy any time after BTK inhibitor treatment of more than 180 days.

At 12 months, approximately 95.3% of individuals treated with ibrutinib had not initiated a next treatment compared with 91.2% of those on acalabrutinib. At 15 months, 94.6% and 88.3% had not initiated next therapy, respectively.

“Insights from real-world data are becoming more important to help physicians understand optimal treatments and sequencing, especially for patients living with chronic diseases like CLL,” Imran Khan, MD, PhD, vice president of Medical Affairs in Oncology at Janssen Biotech Inc, said in the statement. “With nearly 10 years of data since [ibrutinib] was first approved, we are sourcing real-world data to provide insights from large cohorts of patients further supporting [ibrutinib] as a first-line treatment option for CLL.”

The limitations of the study included that the data was based on electronic medical records, which could include potential omissions.

Investigators noted that these would be random and are expected to have a minimal impact on the results of the study.

Further research is warranted with additional follow-up and larger sample size, they said.


Real-world study shows patients treated with Imbruvica (ibrutinib) were less likely to initiate a next-line treatment than patients on acalabrutinib in first-line chronic lymphocytic leukemia. Janssen. News release. December 12, 2022. Accessed December 20, 2022.

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