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Chen CI, Paul H, Le LW, et al. A phase 2 study of ofatumumab (Arzerra. Leuk Lymphoma. 2018;60(1):92-100doi: 10.1080/10428194.2018.1468892.
Chen, C. I., Paul, H., Le, L. W., Wei, E. N., Snitzler, S., Wang, T., Levina, O., Kakar, S., Lau, A., Queau, M., Johnston, J. B., Smith, D. A., & Trudel, S. (2019). A phase 2 study of ofatumumab (Arzerra. Leukemia & lymphoma, 60(1), 92-100. https://doi.org/10.1080/10428194.2018.1468892
Chen, Christine I, et al. "A phase 2 study of ofatumumab (Arzerra." Leukemia & lymphoma vol. 60,1 (2019): 92-100. doi: https://doi.org/10.1080/10428194.2018.1468892
Chen CI, Paul H, Le LW, Wei EN, Snitzler S, Wang T, Levina O, Kakar S, Lau A, Queau M, Johnston JB, Smith DA, Trudel S. A phase 2 study of ofatumumab (Arzerra. Leuk Lymphoma. 2019 Jan;60(1):92-100. doi: 10.1080/10428194.2018.1468892. Epub 2018 Jun 19. PMID: 29916761.
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Leuk Lymphoma. 2019 Jan;60(1):92-100. doi: 10.1080/10428194.2018.1468892. Epub 2018 Jun 19.

A phase 2 study of ofatumumab (Arzerra.

Leukemia & lymphoma

Christine I Chen, Harminder Paul, Lisa W Le, Ellen N Wei, Susi Snitzler, Trina Wang, Olga Levina, Sumeet Kakar, Anthea Lau, Michelle Queau, James B Johnston, Deborah A Smith, Suzanne Trudel

Affiliations

  1. a Princess Margaret Cancer Centre/Ontario Cancer Institute , Toronto , ON , Canada.
  2. b Department of Biostatistics , Princess Margaret Cancer Centre , Toronto , ON , Canada.
  3. c Manitoba Institute of Cell Biology , Winnipeg , MB , Canada.
  4. d Clin Pharm Advantage LLC , Durham , NC , USA.

PMID: 29916761 DOI: 10.1080/10428194.2018.1468892

Abstract

AKT plays a centralized role in tumor proliferation and survival and is aberrantly activated in chronic lymphocytic leukemia (CLL). In this phase 2 trial, 30 relapsed/refractory CLL patients were treated with combination afuresertib, a novel oral AKT inhibitor, and ofatumumab for 6 months, followed by afuresertib maintenance for 12 months. We aimed to achieve deeper and more durable responses, without requiring long-term continuous treatment. Treatment was generally well tolerated but respiratory infections were common, with 18% severe requiring hospitalization. Hematologic toxicities were manageable (grade 3-4 neutropenia 39%). At a median follow-up of 13.4 months, overall responses were 50% (complete responses 3.6%). Median progression-free survival was 8.5 months and overall survival 34.8 months. Combination therapy with ofatumumab and afuresertib is active and well tolerated, but does not appear to lead to durable responses and may not provide additional benefit over single-agent ofatumumab in relapsed/refractory CLL. Novel agent combinations are currently undergoing intense investigation.

Keywords: AKT inhibitor; Lymphoid leukemia; chemotherapeutic approaches; ofatumumab

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