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iwCLL 2025 | The current and future role of pirtobrutinib in the management of CLL
Catherine Coombs, MD, UC Irvine Health, Orange County, CA, comments on the current role of pirtobrutinib in the management of chronic lymphocytic leukemia (CLL), stating that it is her agent of choice in the third-line or later setting. Dr Coombs suggests that findings from the BRUIN-321 trial (NCT04666038) may lead to pirtobrutinib being approved by the FDA as a second-line option. This interview took place at the biennial International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2025 in Krakow, Poland.
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Transcript
So I think the current role of pirtobrutinib as a no-brainer is that it’s my go-to drug in the third line or beyond setting, meaning patients failed by not only covalent BTK inhibitors, but also venetoclax. However, I do think we’ll see a broader label for pirtobrutinib following hopefully an earlier FDA approval based on the BRUIN-321 trial, which may lead to the ability to use it in the second-line space...
So I think the current role of pirtobrutinib as a no-brainer is that it’s my go-to drug in the third line or beyond setting, meaning patients failed by not only covalent BTK inhibitors, but also venetoclax. However, I do think we’ll see a broader label for pirtobrutinib following hopefully an earlier FDA approval based on the BRUIN-321 trial, which may lead to the ability to use it in the second-line space. And this is actually already supported by the NCCN guidelines that list pirto as an option in the second-line space. I think we don’t know if pirto is better than venetoclax in the second line. Obviously, these haven’t been directly compared, but I would consider both reasonable options, and I think should be offered to patients. And often the ultimate decision on what drug is the best for any given patient comes down to not only the efficacy data from these trials, but to some extent patient preference. And so I think one of the beautiful things about pirto is just the pure ease of administration. And so we also now can see data supporting its efficacy in the post-covalent BTKi setting, first from the BRUIN Phase I/II, but also further seen in the BRUIN-321 trial.
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Disclosures
AbbVie, AstraZeneca, BeOne Medicines, Lilly, Genentech, Janssen.
