Eli Lilly and Company has reported the outcomes from the Phase III BRUIN CLL-314 trial of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, against Imbruvica (ibrutinib) for chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).
The patients in this trial were treatment-naïve or BTK inhibitor-naïve.
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The results demonstrated that pirtobrutinib met its primary endpoint of non-inferiority on overall response rate (ORR) against ibrutinib.
It achieved an ORR of 87% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) population.
Pirtobrutinib also indicated numerically higher ORR rates, with immature, progression-free survival (PFS) outcomes in favour of pirtobrutinib, including a 76% decline in disease progression or death risk in treatment-naïve patients.
These results will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida.
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By GlobalDataA total of 662 participants were enrolled in the trial, randomised equally to receive ibrutinib or pirtobrutinib.
The ITT population included 437 relapsed/refractory and 225 treatment-naïve participants. The efficacy data used a 10 June 2025 cut-off.
BRUIN CLL-314 confirmed statistical non-inferiority of pirtobrutinib against ibrutinib in ORR assessed by the independent review committee (IRC). ORR consistently favoured the therapy throughout all evaluated subgroups, including patients with or without 17p deletions, IGHV status, and complex karyotype.
The overall safety profile was similar to prior trials, with most adverse events (AE) of interest being lower than with ibrutinib, including hypertension (10.6% against 15.1%) and atrial fibrillation / flutter (2.4% against 13.5%). Pirtobrutinib had fewer AE-related dose reductions (7.9% against 18.2%) and discontinuations (9.4% against 10.8%) compared to ibrutinib.
Eli Lilly and Company oncology executive vice-president and president Jacob Van Naarden said: “We are excited to share these compelling new findings for pirtobrutinib with the scientific community at ASH and in the Journal of Clinical Oncology.
“These data build on additional results from the BRUIN development programme and the recent FDA approval for pirtobrutinib in the post-covalent BTK inhibitor setting to reinforce the medicine’s potential to deliver meaningful benefit for people living with CLL or SLL across various disease settings.”
In September 2025, Eli Lilly sought a label expansion for earlier use of Jaypirca in treatment-naïve patients with CLL/SLL after it showed success in a Phase III trial.
