Real-world adherence and discontinuation among Medicare beneficiaries initiating venetoclax vs. BTKis in relapsed/refractory chronic lymphocytic leukemia

Abstract

The treatment landscape for chronic lymphocytic leukemia (CLL) has been transformed by the availability of Bruton’s tyrosine kinase inhibitors (BTKis) and the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax. Despite clinical trial data supporting these novel oral agents, evidence evaluating real-world adherence is limited. This study used 2015–2019 Medicare claims data for elderly patients with relapsed/refractory CLL to assess differences in real-world adherence and discontinuation in the 12 months after treatment initiation. In the final sample of 711 venetoclax patients and 1,566 BTKi patients, we found that those initiating venetoclax tended to be younger (mean age 75.6 [SD 6.0] vs 77.6 [SD 6.9] years, p < .001) but had poorer clinical characteristics. After risk-adjustment, the venetoclax group had higher adherence (61.9% vs. 45.4%, p < .0001) and lower discontinuation when compared to the BTKi group (28.5% vs. 47.4%, p < .001). These favorable real-world findings underscore the importance of developing well-tolerated novel combinations for older adults.

Keywords:

• CLL
• venetoclax
• adherence
• discontinuation
• BTKi

Disclosure statement

JTP, SKB: full-time employees of COVIA Health Solutions, a consulting firm with clients in the biotech/pharmaceutical industry; BSM, HA, DJ: employees of AbbVie Inc. and may hold stock or stock options; AR: employee of Genentech Inc. and may hold stock or stock options; SFH: consultancy for Janssen, Pharmacyclics, AbbVie, AstraZeneca, Flatiron Health Inc., Novartis, SeaGen, Genetech, Merck, TG Therapeutics, ADC Therapeutics, Epizyme, Servier, Arvinas, and Thyme Inc.; research funding from Celgene, DTRM Biopharm, and TG Therapeutics; honoraria form Pharmacyclics and AstraZeneca, Bayer; JAD: consultancy for AbbVie, Acadia, Allergan, Boehringer Ingelheim, Catabasis, Ironwood Pharmaceuticals, Janssen, Kite Pharma, MeiraGTx, Merck, Otsuka, Regeneron, Sarepta, Sage Therapeutics, Sanofi, Takeda, The Medicines Company, and Vertex; research funding from AbbVie, Biogen, Humana, Janssen, Merck, Novartis, Pfizer, PhRMA, Regeneron, Sanofi, and Valeant.

Data availability statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g. protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

Additional information

Funding

This work was supported by AbbVie Inc. and Genentech Inc. Venetoclax is being developed in a collaboration between AbbVie Inc. and Genentech Inc. AbbVie Inc. and Genentech Inc. sponsored the study and participated in the design; study conduct; interpretation of the data; and the writing, review, and approval of the publication. No honoraria or payments were made for authorship. All authors contributed to the development of the publication and maintained control over the final content.