SAN DIEGO — In this video, Ryan W. Jacobs, MD, head of the clinical trials program for chronic lymphocytic leukemia at the Levine Cancer Institute, reviews phase 3 data from the ALLIANCE trial, which showed ibrutinib alone or in combination with rituximab prolonged PFS compared with bendamustine plus rituximab among treatment-naive patients with chronic lymphocytic leukemia.
“This study was looking at two different questions,” Jacobs said. “The more important question was, if ibrutinib is used in the first-line setting, is it better than standard chemoimmunotherapy? ...The second, less significant question that was investigated, which has previously been investigated as recently as last ASH, was, is the addition of rituximab to ibrutinib worth doing?”
The trial included 547 previously untreated patients aged 65 to 89 years who were randomly assigned to one of three treatment groups: the standard-of-care chemotherapy/antibody regimen of bendamustine plus rituximab (Rituxan; Genentech, Biogen); ibrutinib alone (Imbruvica; Pharmacyclics, Janssen); or ibrutinib plus rituximab.
The results, which were presented during the plenary session at the ASH Annual Meeting and Exposition, showed that a higher proportion of patients in the ibrutinib plus rituximab arm achieved 2-year PFS (88%; 95% CI, 81-92) compared with patients in the ibrutinib monotherapy arm (87%; 95% CI, 81-92) or bendamustine and rituximab arm (74%; 95% CI, 66-80).
“Based on these data, we can definitely say that ibrutinib is superior to chemoimmunotherapy with bendamustine/rituximab in the front-line setting in terms of PFS,” Jacobs said. “The data are not mature enough yet for an OS benefit.”
The results further showed that the addition of rituximab to ibrutinib did not significantly improve outcomes.
“The current FDA recommendation of ibrutinib as a single agent remains appropriate,” Jacobs said. “That is where practice will continue until perhaps we get more data on novel combinations with ibrutinib. The most exciting seemingly to be combinations involving BCL-2 inhibition with venetoclax in addition to ibrutinib.”
Woyach JA, et al. Abstract 6. Presented at: ASH Annual Meeting and Exposition; Dec. 1-4, 2018; San Diego.
Disclosure: Jacobs reports research funding from Pharmacyclics and honoraria from Genentech, Janssen and Pharmacyclics.