Real-world experience of Australian and New Zealand patients with chronic lymphocytic leukemia and mantle cell lymphoma accessing ibrutinib through a Named Patient Program

Abstract

Ibrutinib is a small molecule inhibitor of Bruton’s tyrosine kinase indicated for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). The Named Patient Program in Australia and New Zealand (ANZ NPP) provided access to ibrutinib treatment to 1126 R/R CLL/SLL and 330 R/R MCL patients, prior to Pharmaceutical Benefits Scheme listing. This study aimed to assess the duration of treatment for the ANZ NPP patients, as an indicator of efficacy and tolerability of ibrutinib in the real world. Based on the NPP data, ibrutinib provided a median of 47 months clinical benefit for participants with CLL/SLL and 14 months clinical benefit for those with MCL; outcomes that are consistent with the clinical trial results and further support the well-established efficacy and safety profile of ibrutinib in the real world.

Keywords:

• Ibrutinib
• real-world
• mantle cell leukemia
• chronic lymphocytic leukemia

Acknowledgements

The authors thank Pippa Burns, PhD, CMPP & Anne Dyson MBBS, of WriteSource Medical Pty Ltd, Sydney, Australia, for providing medical writing support. Medical writing support was funded by Janssen-Cilag Australia in accordance with Good Publication Practice (GPP2022) guidelines (https://www.ismpp.org/gpp-2022).

Geolocation information

Australia and New Zealand.

Disclosure statement

SPM has acted as a consultant/advisor for AbbVie, AstraZeneca, BeiGene, Janssen, Gilead, and Roche. SO has acted as a consultant/advisor for AbbVie, AstraZeneca, BeiGene, Janssen, Gilead, Roche, Mundipharma, Merck, and Bristol Myers Squibb; has received research funding from AbbVie, AstraZeneca, BeiGene, Janssen, Gilead, Roche, and Epizyme; and has received honoraria from AbbVie, AstraZeneca, BeiGene, Janssen, Gilead, Roche, Merck, and Bristol Myers Squibb. CYC has acted as a consultant/advisor/honoraria for Roche, Janssen, MSD, Gilead, AstraZeneca, Lilly, TG Therapeutics, BeiGene, Novartis, and BMS. BK notes honoraria, consultancy, and advisory boards for Roche, AbbVie, Janssen, Mundipharma, Takeda, Gilead, Merck, CSL, Pharamacyclics, and AstraZeneca, speaker fees from Gilead, Janssen, Roche, AbbVie, and AstraZeneca, and conference registration from AbbVie, Roche, and AstraZeneca. MH has acted as a consultant/advisor/honoraria for Roche, Janssen, Gilead, BeiGene, Novartis, Takeda, Otsuka, and MSD. PM has acted as a consultant/advisor/speaker/honoraria for AbbVie, Astellas, Astra Zeneca, Roche, Janssen, Jazz, Gilead, BeiGene, Novartis, and Otsuka. SP has nothing to declare. AP & MMcG are both employees of Janssen-Cilag Australia Pty Ltd. RW has received honoraria and speaker fees from Janssen, AbbVie, and speaker fees from Beigene. CT has received research funding from Janssen, AbbVie, and Beigene; honoraria from Janssen, AbbVie, and Beigene.

Data availability statement

Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available.

Additional information

Funding

The study was sponsored by Janssen-Cilag Australia, the sponsor of ibrutinib (Imbruvica) in Australia and New Zealand.