Lilly’s Jaypirca shows positive results in phase 3 trial
Eli Lilly and Company announced positive topline results from its phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib) for chronic lymphocytic leukaemia. The trial showed non-inferiority in overall response rate compared to Imbruvica, with a nominal P-value for superiority below 0.05. While progression-free survival data were immature, a trend favored pirtobrutinib. The safety profile was consistent with previous studies. Full results will be presented in 2025, and further studies are planned to support regulatory submissions.
Eli Lilly and Company has announced positive topline results from its phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib) in patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma.
The study compared pirtobrutinib, a non-covalent BTK inhibitor, with Imbruvica (ibrutinib), a covalent BTK inhibitor, in treatment-naïve and previously treated BTK inhibitor-naïve patients.
Pirtobrutinib met the primary endpoint of overall response rate non-inferiority, as assessed by an independent review committee. The response rate favoured pirtobrutinib, with a nominal P-value for superiority below 0.05.
Progression-free survival data were immature at the time of analysis but showed a trend in favour of pirtobrutinib. No detriment was observed for overall survival.
BRUIN CLL-314 is the first head-to-head phase 3 trial in CLL to include treatment-naïve patients. This subgroup showed a particularly pronounced progression-free survival effect size.
The safety profile of pirtobrutinib was consistent with previous studies. Full results will be presented at a medical congress later in 2025.
Jacob Van Naarden, executive vice president and president of Lilly Oncology said: “These data mark the second positive phase 3 study in the programme, as we continue to build evidence supporting the potential role of pirtobrutinib in treating people with CLL/SLL.”
The results build on earlier data from the BRUIN phase 1/2 and phase 3 CLL-321 trials. A further phase 3 study, BRUIN CLL-313, is expected to report later in 2025 and, together with CLL-314, will support global regulatory submissions.
