Adverse events of special interest that have been reported with ibrutinib included atrial fibrillation and bleeding events. Atrial fibrillation occurred in 4% of the ibrutinib-treated patients and 1% of temsirolimus-treated patients; bleeding rates were similar between the 2 groups.

Patients with mantle cell lymphoma who are refractory to, or relapse on, rituximab-based therapy have poor response to chemotherapy and generally experience rapid disease progression, with median OS between 1 and 2 years.

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Dr Martin noted that “phase 2 trials in oncology can be deceptively convincing,” including potentially overstating the efficacy of temsirolimus in mantle cell lymphoma.2 Thus, this phase 3 trial adds confidence in the results of earlier trials demonstrating ibrutinib efficacy in mantle cell lympohoma.

According to the authors, the results confirmed “the favorable benefit-risk ratio for ibrutinib as an effective targeted approach” to treatment of patients with relapsed or refractory mantle-cell lymphoma. The future role of ibrutinib in mantle-cell lymphoma is likely to increase.1

Dr Martin stated that within 2 years, many clinicians expect that “ibrutinib will find its way into the front-line setting for treatment of mantle cell lymphoma in combination with standard chemotherapy.”2

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However, he cautioned that as many as 40% of patients do not respond to ibrutinib and these patients appeared to have a very poor prognosis. He added that even with the advance represented by ibrutinib, “mantle cell lymphoma remains incurable.”

References

  1. Dreyling M, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387(10020):770-778.
  2. Martin P. Ibrutinib—a new standard treatment for mantle cell lymphoma? [editorial]. Lancet. 2016;387(10020):728-729.
  3. Hess G, Herbrecht R, Romaguera J, et al. Phase III study to evaluate temsirolimus compared with investigator’s choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009;27(23):3822-3829.
  4. Advani RH, Buggy JJ, Sharman JP, et al. Bruton kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013;31(1):88-94.
  5. Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369(6):507-516.
  6. Wang ML, Blum KA, Martin P, et al. Long-term follow-up of MCL patients treated with ibrutinib: updated safety and efficacy results. Blood. 2015;126(6):739-745.
  7. Wang ML, Lee H, Chuang H, et al. Ibrutinib in combination with rituximab in relapses or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial. Lancet Oncol. 2016;17(1):48-56.

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Hematologic Cancers Lymphoma