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Frontline Ibrutinib Plus R-CHOP Misses Primary Endpoint in Phase III DLBCL Trial

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 11, 2018

Thorsten Graef, MD, PhD

Thorsten Graef, MD, PhD

Combining ibrutinib (Imbruvica) with standard R-CHOP did not improve event-free survival versus R-CHOP alone in the first-line setting for patients with diffuse large B-cell lymphoma (DLBCL), missing the primary endpoint of the phase III DBL3001 study.

The most frequent grade 3/4 adverse events were neutropenia (15), thrombocytopenia (7), anemia (5), and syncope (3). Two patients (both in the 280-mg cohort) developed febrile neutropenia during a cumulative total of 91 cycles of therapy among the 17 patients entered into the dose-finding stage.
Younes A, Flinn I, Berdeja JG, et al. Phase Ib study combining ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL). J Clin Oncol. 2013;31(suppl; abstr 8502).

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