Phase III data on Imbruvica for CLL/SLL published in NEJM - Pharmacyclics

Pharmacyclics has announced trial results of the first Phase III study (RESONATE, PCYC-1112-CA), a head-to-head comparison of Imbruvica (ibrutinib) versus ofatumumab in patients with previously treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL). Patients receiving Imbruvica realized a significant improvement in progression free survival (PFS), overall survival (OS) and overall response rate (ORR) as compared to patients receiving ofatumumab.

Results show that Imbruvica significantly prolonged PFS in patients with relapsed/refractory CLL in comparison to those randomized to receive ofatumumab. Patients treated with Imbruvica experienced a 78% reduction in risk of progression or death versus patients receiving ofatumumab. The median PFS for IMBRUVICA was not reached with a median time on study of 9.4 months. The median PFS for ofatumumab was 8.1 months. IMBRUVICA significantly prolonged OS compared with ofatumumab. Imbruvica reduced the risk of death by 57% compared to the ofatumumab arm, despite a total of 57 patients who were initially randomized to ofatumumab crossing over to receive Imbruvica prior to the analysis.

Investigator assessed overall response rate was 85% for Imbruvica and 23% for patients receiving ofatumumab. The most commonly occurring adverse events were diarrhea and fatigue. Data were presented at the American Society of Clinical Oncology (ASCO) and have been published online in the New England Journal of Medicine: "Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia" John C. Byrd et al. NEJM May 31, 2014 DOI:10.1056/NEJMoa1400376