Phase 3 study reports that ibrutinib plus rituximab produces better outcomes than standard chemoimmunotherapy in younger people with previously untreated chronic lymphocytic leukaemia (CLL).
Ibrutinib is a type of drug called a cell signal blocker. It inhibits a protein called BTK on B cells. This blocks the signals that help B cells to stay alive and divide. It is given as a tablet once a day. In the UK, it is sometimes used on its own for people with previously untreated CLL who have high-risk genetic mutations. It is also used on its own or in combination with other medicines for people with CLL that has relapsed or is refractory to first-line treatment.
In this trial, people under 70 with CLL that had not been treated before were given either ibrutinib plus the antibody therapy rituximab, or standard chemoimmunotherapy with FCR (fludarabine, cyclophosphamide and rituximab).
After an average follow-up of almost 3 years, outcomes were significantly better for people treated with ibrutinib plus rituximab than people treated with FCR. People treated with the ibrutinib combination not only experienced longer responses, but also had an overall survival advantage.
Similar numbers of people in each treatment group experienced side effects, although the most common side effects were different for each regimen. Ibrutinib plus rituximab was associated with a lower rate of neutropenia (low neutrophil count) and infections than FCR, but a higher rate of high blood pressure and bleeding.
It is important to note that this is an interim analysis, which means the clinical trials is still ongoing and not all the data has been collected yet. So far, the numbers of participants analysed is small. However, the board monitoring the safety of the clinical trial recommended releasing the results immediately because they were deemed to be potentially practice-changing.
The interim results were first released at the American Society of Hematology’s annual meeting last November. They have now been published in more detail in the New England Journal of Medicine.
To find out more about clinical trials for lymphoma, or to search for a trial that might be suitable for you, visit Lymphoma TrialsLink.
03 September 2019