Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenström's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study.
Christian Buske, Alessandra Tedeschi, Judith Trotman, Ramón García-Sanz, David MacDonald, Veronique Leblond, Beatrice Mahe, Charles Herbaux, Jeffrey V Matous, Constantine S Tam, Leonard T Heffner, Marzia Varettoni, M Lia Palomba, Chaim Shustik, Efstathios Kastritis, Steven P Treon, Jerry Ping, Bernhard Hauns, Israel Arango-Hisijara, Meletios A Dimopoulos
J Clin Oncol | Published : 2022
PURPOSE: The double-blind, randomized, placebo-controlled phase III iNNOVATE study showed sustained efficacy of ibrutinib-rituximab in Waldenström's macroglobulinemia (WM). Here, we present the final analysis from iNNOVATE. METHODS: Patients had confirmed symptomatic WM, either previously untreated or previously treated; patients with prior rituximab had at least a minor response to their last rituximab-based regimen. Patients were randomly assigned to once-daily ibrutinib 420 mg plus rituximab or placebo plus rituximab (n = 75 per arm). The primary end point was progression-free survival (PFS). Secondary end points included response rate, time to next treatment, hemoglobin improvement, over..View full abstract