Ibrutinib plus rituximab as a new standard treatment option

<p class="article-intro">The randomized phase-III-trial iNNOVATE demonstrates that patients with Waldenström’s Macroglobulinemia have superior PFS outcomes when treated with ibrutinib + rituximab compared to placebo + rituximab.</p> <hr /> <p class="article-content"><p>Waldenstr&ouml;m&rsquo;s Macroglobulinemia (WM) is a rare type of blood cancer. Therefore it is difficult to conduct large clinical studies and determine a standard treatment for the disease. Rituximab is effective and commonly used in treating WM, by itself or when given with other treatments. Ibrutinib, an oral, once-daily inhibitor of Bruton&rsquo;s tyrosine kinase, is approved in the US for adults with WM and in the EU for adults previously treated for WM or with untreated WM that could not tolerate/receive chemotherapy.&nbsp;</p> <p>In this iNNOVATE-trial, 150 patients with WM were randomly assigned to receive treatment with either ibrutinib + rituximab or placebo + rituximab. More patients had a better major response rate to treatment with ibrutinib + rituximab (72 % ) than with placebo + rituximab (32 % ). At 30 months after starting treatment, an estimated 82 % of patients treated with ibrutinib + rituximab were alive and did not have disease progression versus 28 % of patients treated with placebo + rituximab. It was estimated that 94 % of patients treated with ibrutinib + rituximab and 92 % of patients treated with placebo + rituximab would still be alive at 30 months after starting treatment.&nbsp;</p> <p>Approximately 60 % of patients in both treatment groups experienced at least one significant (grade &ge;3) side effect; the most common grade &ge;3 side effects with ibrutinib + rituximab were hypertension and atrial fibrillation. Ending treatment with ibrutinib or placebo because of side effects was uncommon (&le;5 % of patients in both treatment groups). Based on the data from this study, ibrutinib + rituximab could become a standard treatment option for WM.&nbsp;</p> <p><strong><em>Reference: </em></strong></p> <p><em>Dimopoulos M et al.: Multinational, randomized phase 3 trial of ibrutinib-rituximab vs placebo-rituximab in patients with Waldenstr&ouml;m&rsquo;s Macroglobulinemia. EHA Annual Congress, abstract # S852</em></p></p>