Mitchell R. Smith, MD, PhD, discusses two randomized phase III trials investigating the benefit of ibrutinib-based therapies in patients with chronic lymphocytic leukemia.
Mitchell R. Smith, MD, PhD, professor of medicine, George Washington University, associate center director for clinical investigations, Division of Hematology and Oncology, GW Cancer Center, discusses two randomized phase III trials investigating the benefit of ibrutinib (Imbruvica)-based therapies in patients with chronic lymphocytic leukemia (CLL).
The phase III ECOG E1912 trial accrued 529 previously untreated patients under the age of 70 and randomized them to receive the combination of ibrutinib and rituximab (Rituxan) or standard fludarabine, cyclophosphamide, and rituximab (FCR).
In the phase III ALLIANCE A041202 trial, investigators tested ibrutinib with or without rituximab versus the combination of bendamustine and rituximab. There were 547 patients in the trial, and patients had a median age of 71.
In both trials, a progression-free survival (PFS) benefit was reported with the use of ibrutinib. In ECOG E1912, a 65% reduction in the risk of disease progression or death was reported with ibrutinib compared with FCR. In the ALLIANCE study, a 63% reduction in the risk of disease progression or death was reported with ibrutinib.
Notably, no significant benefit was seen with the addition of rituximab in the ALLIANCE trial; therefore, single-agent ibrutinib is recommended, Smith concludes.