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Original Articles

Bendamustine in combination with ofatumumab as first line treatment for elderly patients with mantle cell lymphoma: a phase II risk-adapted design

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Pages 2889-2896 | Received 28 Mar 2022, Accepted 26 Jul 2022, Published online: 16 Aug 2022
 

Abstract

This study evaluated ofatumumab (Ofa), an anti-CD20 monoclonal antibody, alone or with bendamustine (Benda), in transplant-ineligible patients with mantle cell lymphoma. Low-risk patients received Ofa monotherapy. Non-responders received subsequent treatment with Benda-Ofa. Six patients received Ofa monotherapy and 3 patients crossed over to Bend-Ofa. Twenty-four high-risk patients were initially treated with Benda-Ofa. The overall response rate for patients treated with Ofa monotherapy was 1/6 (17%) and 23/25 (92%) for patients treated with Benda-Ofa. With a median follow-up of 8.6 years, all Ofa patients progressed with a median progression-free survival (PFS) of 0.6 years (95% CI 0.31-NR) and remain alive. With a median follow-up of 6.3 years, Bend-Ofa treated patients had median PFS 2.5 years (95% CI 1.8-NR) and a median overall survival of 7.4 years (95% CI 5.8-NR). Benda-Ofa had a favorable adverse event profile and efficacy similar, but not clearly superior, to those reported for Benda-Rituximab.

Acknowledgements

PH and CC designed the study. AK, AY, CC, CM, AM, PD, PH, JG, AZ, MC, CG, LL, DS, and AJ collected the data. AK and ED analyzed the data. AK wrote the manuscript. All authors reviewed, revised, and approved the final manuscript for publication.

Disclosure statement

AK receives research funding from Abbvie, Adaptive Biotechnologies, Celgene, Pharmacyclics, and Seattle Genetics; member of the advisory board for Celgene, Kite Pharma, AstraZeneca and the Summit Advisory Committee; has served on the steering committee for the MCL Registry with AstraZeneca. JG is currently employed by Janssen Pharmaceuticals. The remaining authors do not have any conflicts of interest to report.

Additional information

Funding

The author(s) reported there has been funding from Novartis Pharmaceuticals.