Imbruvica Ibrutinib: Additional Phase III data

Additional data from the open-label, international Phase III RESONATE (PCYC-1112-CA) trial in 391 patients with relapsed or refractory CLL or SLL showed that median PFS -- the primary endpoint -- was not reached at a median follow-up of 16 months in patients receiving once-daily 420 mg oral Imbruvica vs. 8.1 months in patients receiving IV Arzerra ofatumumab (HR=0.106, 95% CI: 0.073, 0.153, p<0.0001). The 12-month PFS rate was 84% in the Imbruvica arm vs. 19% in the Arzerra arm. The 18-month OS rate was 85% in the Imbruvica arm vs. 78% in the Arzerra arm. Patients received Imbruvica or Arzerra over the course of 24 weeks until disease progression or toxicity. Patients in the Arzerra arm who experienced disease progression were evaluable for consideration of subsequent Imbruvica therapy. Data were presented at the American Society of Hematology meeting in San Francisco. RESONATE was stopped early on the recommendation of an IDMC after an interim analysis showed that Imbruvica met the primary endpoint (see BioCentury, Jan. 13 & June 9). ...