Jaypirca significantly extended progression-free survival in the Phase 3 BRUIN CLL-322 clinical trial, according to a recent announcement from Eli Lilly and Company. The topline results demonstrate that the addition of Jaypirca (pirtobrutinib) to a time-limited regimen of venetoclax and rituximab (PVR) provides a statistically significant benefit for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Jaypirca Significantly Extended Progression-Free Survival: Clinical Breakthrough
The BRUIN CLL-322 trial is the first Phase 3 readout to utilize and outperform a venetoclax-containing control arm in this patient population. The study enrolled 639 patients who had received at least one prior line of therapy. By meeting its primary endpoint, the trial confirmed that Jaypirca significantly extended progression-free survival when compared to the standard venetoclax plus rituximab (VR) regimen.
Trial Design and Key Findings
Patients in the experimental arm received pirtobrutinib 200 mg once daily in combination with the fixed-duration VR regimen for up to two years. Following this period, patients discontinued all therapy until disease progression. The benefit was observed across all clinically relevant subgroups, including those previously treated with covalent BTK inhibitors.
Read More: Lilly’s Jaypirca Outperforms Imbruvica in Landmark Phase 3 Trial for CLL/SLL
Efficacy and Safety Profile
While overall survival (OS) data were a key secondary endpoint, they were not yet mature at the time of this analysis, the results showed a favorable trend toward the pirtobrutinib-containing arm. The safety profile remained consistent with the established characteristics of each medication.
BRUIN CLL-322 was an ambitious trial, and these results outperformed our expectations,
The data reinforce that Jaypirca significantly extended progression-free survival and could further extend the duration of benefit in the second-line setting for patients seeking a time-limited approach.
Jacob Van Naarden, Executive Vice President and President of Lilly Oncology
Phase 3 BRUIN CLL-322 Trial Characteristics
| Parameter | PVR (Pirtobrutinib + Venetoclax + Rituximab) | VR (Venetoclax + Rituximab) |
| Patient Population (N) | ~320 | ~319 |
| Primary Endpoint | Progression-Free Survival (IRC-assessed) | Progression-Free Survival (IRC-assessed) |
| PFS Status | Met (Statistically Significant) | Control Arm |
| Time-Limited Duration | Up to 2 Years | Up to 2 Years |
Key Safety and Adverse Events (Pooled Population)
| Parameter | PVR (Pirtobrutinib + Venetoclax + Rituximab) | VR (Venetoclax + Rituximab) |
| Patient Population (N) | ~320 | ~319 |
| Primary Endpoint | Progression-Free Survival (IRC-assessed) | Progression-Free Survival (IRC-assessed) |
| PFS Status | Met (Statistically Significant) | Control Arm |
| Time-Limited Duration | Up to 2 Years | Up to 2 Years |
Next Steps for Jaypirca
Eli Lilly plans to present the full detailed findings at an upcoming medical congress and will submit the data to global regulatory authorities later this year. This latest milestone builds on the growing body of evidence for Jaypirca, which has already received FDA approval for certain indications in MCL and CLL/SLL.
