Phase III study (E1912) of Imbruvica + Rituxan shows improved PFS in chronic/small lymphocytic leukemia.- Janssen.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase III study (E1912) led by the ECOG-ACRIN Research Group (ECOG-ACRIN) evaluating Imbruvica (ibrutinib) plus Rituxan (rituximab) compared to a chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in previously untreated patients aged 70 years or younger with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). With nearly three years of follow-up, the data showed ibrutinib plus rituximab significantly prolonged progression-free survival (PFS) and overall survival (OS) versus FCR. At a median follow-up of 33.4 months, ibrutinib plus rituximab showed significantly prolonged PFS compared to FCR in previously untreated patients aged 70 years or younger with CLL/SLL. The study also demonstrated an improved OS for the ibrutinib plus rituximab treatment arm versus FCR.

In a subgroup analysis for PFS, ibrutinib plus rituximab showed prolonged PFS independent of age, sex, performance status (0-2), disease stage, or the presence/absence of deletion 11q23. Grade 3/4 treatment-related adverse events were observed in 58 percent of ibrutinib plus rituximab treated patients and 72 percent of FCR treated patients (p=0.0042). The findings were presented at the 60th American Society of Hematology (ASH) Annual Meeting.