Journal article
Authors list: Rummel, Mathias J.; Janssens, Ann; MacDonald, David; Keating, Mary-Margaret; Zaucha, Jan M.; Davis, Jaclyn; Lasher, Janet; Pisal, Chaitali Babanrao; Izquierdo, Miguel; Friedberg, Jonathan W.
Publication year: 2021
Pages: 1123-1133
Journal: British Journal of Haematology
Volume number: 193
Issue number: 6
ISSN: 0007-1048
eISSN: 1365-2141
DOI Link: https://doi.org/10.1111/bjh.17420
Publisher: Wiley
Abstract:
The standard of care for indolent non-Hodgkin lymphoma (iNHL) is rituximab, an anti-CD20 antibody, with/without chemotherapy. However, multiple relapses are common in these patients. This phase 3, randomized study compared outcomes of a combination of ofatumumab (a second-generation anti-CD20 antibody) and bendamustine, with bendamustine alone in patients unresponsive to prior rituximab-based treatment. Overall, 346 patients were randomized to receive either the combination or bendamustine alone. Bendamustine was given for <= 8 cycles and ofatumumab for <= 12 cycles. The primary end-point was progression-free survival (PFS) after 215 protocol-defined events assessed by independent review committee (IRC). Median IRC-assessed PFS was 16 center dot 7 and 13 center dot 8 months in the combination and monotherapy arms respectively [hazard ratio (HR) = 0 center dot 82; P = 0 center dot 1390]. Median overall survival (OS) was 58 center dot 2 and 51 center dot 8 months in the combination and monotherapy arms respectively (HR = 0 center dot 89, P = 0 center dot 4968). The safety profile was consistent with previous reports. Overall, 73% and 80% of patients in the combination and monotherapy arms, respectively, experienced a >= grade 3 adverse event. The study did not meet its primary end-point. No significant improvement in PFS and OS was seen with the combination of ofatumumab and bendamustine as compared with bendamustine alone in rituximab-refractory iNHL (NCT01077518).
Citation Styles
Harvard Citation style: Rummel, M., Janssens, A., MacDonald, D., Keating, M., Zaucha, J., Davis, J., et al. (2021) A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A plus B study), British Journal of Haematology, 193(6), pp. 1123-1133. https://doi.org/10.1111/bjh.17420
APA Citation style: Rummel, M., Janssens, A., MacDonald, D., Keating, M., Zaucha, J., Davis, J., Lasher, J., Pisal, C., Izquierdo, M., & Friedberg, J. (2021). A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A plus B study). British Journal of Haematology. 193(6), 1123-1133. https://doi.org/10.1111/bjh.17420
Keywords
anti‐; ANTI-CD20 MONOCLONAL-ANTIBODY; bendamustine; CD20; FLUDARABINE; FOLLICULAR LYMPHOMA; Hodgkin lymphoma; LOW-GRADE; MAINTENANCE THERAPY; MANTLE-CELL LYMPHOMAS; MULTICENTER; NON-HODGKINS-LYMPHOMA; ofatumumab; OPEN-LABEL; refractory indolent non‐; RELAPSED INDOLENT; RITUXIMAB; rituximab‐
