The phase III E1912 clinical study showed superior progression-free survival and overall survival in patients with chronic lymphocytic leukemia new to treatment.
AbbVie sponsors the study, which was designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by NCI.
These results demonstrated the benefits of Imbruvica (ibrutinib) plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab for previously untreated patients with CLL aged 70 years or younger, the company said.
These results were presented Dec. 7 at the American Society of Hematology annual meeting, and served as the basis of the recent supplemental New Drug Application FDA, to expand the Imbruvica prescribing label in CLL.
Additionally, a new integrated analysis of up to six years of long-term follow-up from the phase III RESONATE and RESONATE-2 studies will be presented on Dec. 8 at ASH, evaluating the use of Imbruvica monotherapy in previously untreated patients. Results showed better PFS, OS and overall response rate, with good tolerability compared to use in the relapsed/refractory setting.
“These latest findings add to the extensive clinical evidence supporting the use of Imbruvica, the most comprehensively studied BTK inhibitor in CLL, as both a single-agent and as a combination regimen to improve patient outcomes in early lines of treatment, which has previously been reserved for chemoimmunotherapy,” Danelle James, Imbruvica Clinical Development Lead of Pharmacyclics LLC, an AbbVie company, said in a statement.
“Phase III RESONATE and RESONATE-2 trials have proven to be cornerstone studies that have significantly advanced the treatment of CLL among a variety of patients—and the latest data presented at this year’s ASH Annual Meeting demonstrate using IMBRUVICA alone and earlier in CLL treatment results in improved patient outcomes,” Paul M. Barr, study investigator of the Phase III RESONATE and RESONATE-2 trials, and associate professor of medicine, Hematology/Oncology at the Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, said in a statement. “These results reaffirm the sustained disease control and safety profile of Imbruvica and further support its use as a chemotherapy-free option for previously untreated patients living with this common form of adult leukemia.”
Imbruvica is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
