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Leukemia/Lymphoma Drug Ibrutinib (Imbruvica) Meets Primary Endpoint in Phase III Study

Treatment improves progression-free survival versus ofatumumab (January 7)

A phase III trial of ibrutinib (Imbruvica, Janssen) in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) has been stopped early based on the recommendation of an independent data monitoring committee (IDMC), which concluded that the study showed a significant difference in progression-free survival (PFS) compared with the control agent — the trial’s primary endpoint.

Study PCYC-1112-CA (RESONATE) is an international, randomized, open-label phase III clinical trial involving 391 patients with relapsed or refractory CLL/SLL with measurable nodal disease who were not eligible for treatment with purine analog-based therapy and who had received at least one prior therapy. Patients were randomly assigned to receive 420 mg of ibrutinib orally once daily or intravenous doses of ofatumumab (Arzerra, GlaxoSmithKline), an approved treatment for relapsed/refractory CLL, over 24 weeks. Both treatments were administered until disease progression or unacceptable toxicity occurred.

The IDMC unanimously recommended stopping the study early based on a planned interim analysis, in which statistically significant differences in PFS and overall survival were observed. The IDMC agreed that these results suggested evidence of clinical benefit as well as a tolerable safety profile in patients treated with ibrutinib compared with intravenous doses of ofatumumab. The IDMC also recommended that ibrutinib be provided to patients in the ofatumumab arm.

Imbruvica (ibrutinib) was approved in November 2013 in the U.S. as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication was based on the overall response rate. An improvement in survival or in disease-related symptoms has not been established.

Source: Johnson & Johnson; December 7, 2013.

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