Journal article
Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenstrom's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study
Christian Buske, Alessandra Tedeschi, Judith Trotman, Ramon Garcia-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
JOURNAL OF CLINICAL ONCOLOGY | LIPPINCOTT WILLIAMS & WILKINS | Published : 2022
DOI: 10.1200/JCO.21.00838
Abstract
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, overal..
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Funding Acknowledgements
Supported by Pharmacyclics LLC, an AbbVie Company. Pharmacyclics LLC sponsored and designed the study. Study investigators and their research teams collected the data. The sponsor confirmed data accuracy and performed analysis of the data. Medical writing support was funded by the sponsor. Editorial support was provided by Cindi Hoover, PhD, and funded by Pharmacyclics LLC, an AbbVie Company.