Real-world evidence of obinutuzumab and venetoclax in previously treated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

Abstract

Venetoclax-obinutuzumab (Ven-O) is frequently administered off-label in relapsed/refractory (r/r) CLL/SLL where venetoclax-rituximab is the approved regimen. We conducted this retrospective, real-world study to evaluate Ven-O in r/r CLL/SLL. Between 7/2019 and 6/2022, 40 patients with r/r CLL/SLL on Ven-O were included. The median age was 72, 28.2% had TP53 mutation and/or 17p deletion, median number of prior therapies was 1 (range, 1–6), and 55% had prior BTK inhibitor exposure. The overall response rate was 90% (complete response [CR] or CR with incomplete marrow recovery in 27.5% and partial response in 62.5%) of patients, and the 2-year progression-free survival was 81.2% (95% CI, 69.5–94.8). Therapy was well tolerated. No laboratory or clinical TLS occurred with venetoclax (Howard criteria). One (3%) patient experienced laboratory TLS with obinutuzumab initiation. In summary, this retrospective cohort study demonstrated that Ven-O achieves frequent, durable responses and can be safely administered in r/r CLL/SLL.

Keywords:

• CLL/SLL (or chronic lymphocytic leukemia/small lymphocytic lymphoma)
• venetoclax
• obinutuzumab
• relapsed
• refractory

Acknowledgements

Study data were collected and managed using REDCap electronic data capture tools hosted at Mass General Brigham. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing (1) an intuitive interface for validated data entry; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for importing data from external sources. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health.

Disclosure statement

Josie Ford, Ronald A. Nemec, Andrea Medrano, and Michelle Yu report no conflict of interest. Matthew M. Lei reports consulting fees from BTG Therapeutics, AstraZeneca, Genentech, Genmab, MJH Life Sciences, and TScan Therapeutics. Uvette Lou reports consulting fees from MJH Life Sciences. Mark N. Sorial reports consulting fees from The Dedham Group, Gerson Lehrman Group, and MJH Life Sciences. Jeremy S. Abramson reports consulting fees from BeiGene, Bluebird Bio, Kymera, Genentech, Incyte, Kite Pharma, Epizyme, Genmab, Bristol Myers Squibb, Ono Pharma, Mustang Bio, Century Therapeutics, AstraZeneca, AbbVie, Lilly, Takeda, Caribou Biosciences, Interius, MorphoSys, Regeneron, Janssen, Incyte, AbbVie, and Cellectar, and research funding paid to institution from Bristol Myers Squibb, Seattle Genetics, Merck, Cellectis, and Mustang Bio. Jacob D. Soumerai reports consulting fees from AbbVie, AstraZeneca, BeiGene, Bristol Myers Squibb, Roche, Seattle Genetics, and TG Therapeutics, and research funding paid to institution from Adaptive Biotechnologies, BeiGene, BostonGene, Genentech/Roche, GlaxoSmithKline, Moderna, Takeda, and TG Therapeutics.

Additional information

Funding

JDS is supported by the National Cancer Institute of the National Institutes of Health under award number [K08CA270202]. This work was made possible through the MGH Lymphoma Translational Research and Biobanking Collaborative supported by the Scott Nathan and Laura DeBonis Fund for Clinical Research (J.S.A.).