Eli Lilly is seeking a label expansion for earlier use of Jaypirca (pirtobrutinib) in treatment-naïve patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) after it showed “compelling” success in a Phase III trial.
In the BRUIN CLL-313 study, the non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor trumped treatment with chemoimmunotherapy bendamustine plus rituximab, meeting the study’s primary endpoint and demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS).
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While not sharing the data, Lilly added that the drug indicated one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study.
Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but is currently trending strongly in favour of Jaypirca and will be tested for statistical significance at the time of the primary OS analysis in 2026, as per the company.
The overall safety profile of Jaypirca in BRUIN CLL-313 was generally consistent with previously reported trials across treatment settings.
Detailed results will be presented at a medical congress and submitted to a peer-reviewed journal.
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By GlobalDataThis builds on the previously reported positive results from the BRUIN Phase I/II trial and the Phase III BRUIN CLL-321 trial and BRUIN CLL-314 trial.
Data from the BRUIN CLL-313 and BRUIN CLL-314 studies will form the basis for seeking label expansions in earlier lines of therapy, with global regulatory submissions beginning later this year.
Lilly Oncology president Jacob Van Naarden said: “With this third positive Phase III study, we continue to build the clinical evidence supporting the possible role of Jaypirca in a variety of CLL/SLL treatment settings, including treatment-naïve, BTK inhibitor-naïve, and BTK inhibitor-exposed.”
Jaypirca is 300 times more selective for BTK versus 98% of other kinases tested in preclinical studies. It is a non-covalent (reversible) inhibitor of the enzyme BTK.
It was first granted accelerated approval by the US Food and Drug Administration (FDA) in January 2023 for use in adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
It has since been approved for use in adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
Analysts at Clinical Trials Arena‘s parent company GlobalData believe the drug will hit blockbuster status in 2027, with a 2031 sales forecast of $2.79bn.
Other BTK inhibitors approved in CLL and SLL include AbbVie and Johnson & Johnson’s (J&J) Imbruvica (ibrutinib) and BeOne Medicines (formerly BeiGene) Brukinsa (zanubrutinib). GlobalData predicts a sales forecast for these two therapies of $1.02 and $6.74bn in 2031, respectively.
Imbruvica sales peaked in 2021, at $6.94bn; however, as Brukinsa gained more indications, including follicular lymphoma (FL) on its label, its uptake grew above J&J’s drug.
In July 2025, Lilly announced data from a study that showed Jaypirca to be superior to Imbruvica in CLL and SLL in the Phase III BRUIN CLL-314 trial (NCT05254743).
Based on GlobalData’s sales forecast, although it appears that Jaypirca will be a preferred treatment to Imbruvica, Brukinsa will continue to hold dominance in the BTK space. Brukinsa already holds approval in treatment-naïve CLL and SLL patients.
