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A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab‐refractory iNHL (COMPLEMENT A + B study)

British Journal of Haematology May 14, 2021

Rummel MJ, Janssens A, MacDonald D, et al. - Among patients with indolent non‐Hodgkin lymphoma (iNHL) unresponsive to prior rituximab‐based treatment, this phase 3, randomized study (complement A + B study) was conducted to compare outcomes of a combination of ofatumumab (a second‐generation anti‐CD20 antibody) and bendamustine vs that of bendamustine alone. Progression‐free survival (PFS) following 215 protocol‐defined events, evaluated by an independent review committee (IRC), was the primary endpoint. In the combination and monotherapy arms, the median IRC‐assessed PFS was 16·7 and 13·8 months, respectively. Median overall survival (OS) was found to be 58·2 months in the combination arm and 51·8 months in the monotherapy arm. Primary endpoint was not met. Findings showed that the combination of ofatumumab and bendamustine did not confer any significant improvement in PFS and OS, vs bendamustine alone, in patients suffering from rituximab‐refractory iNHL.

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