1. Pirtobrutinib shows an 80% reduction in disease progression risk. 2. Data will be presented at the 2025 ASH Annual Meeting. 3. Pirtobrutinib is the first non-covalent BTK inhibitor studied in treatment-naïve CLL. 4. Potential regulatory approvals for earlier treatment lines are being pursued. 5. Safety profile shows significantly fewer adverse events than traditional treatments.
FAQ
Why Bullish?
The strong clinical trial results and potential regulatory approvals indicate promising future sales and market positioning for LLY.
How important is it?
The successful trial results and imminent regulatory submissions are critical to LLY's market strategy and revenue potential.
Why Long Term?
Long-term benefits expected as pirtobrutinib may secure a broader market share following regulatory approvals.
Significant Clinical Breakthrough: Lilly's Jaypirca Demonstrates 80% Risk Reduction in Treatment-Naïve CLL/SLL Patients
Eli Lilly and Company (NYSE: LLY) has announced groundbreaking results from the Phase 3 BRUIN CLL-313 clinical trial, showcasing its drug Jaypirca (pirtobrutinib) as a potent treatment option for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This study indicates that treatment with Jaypirca significantly reduces the risk of disease progression or death by 80% compared to the conventional chemoimmunotherapy regimen of bendamustine plus rituximab (BR).
Study Details and Efficacy Results
The BRUIN CLL-313 trial was designed as the first prospective, randomized Phase 3 study to analyze the effectiveness of a non-covalent Bruton tyrosine kinase (BTK) inhibitor in treatment-naïve patients without 17p deletions. The study enrolled 282 patients, who were evenly divided between continuous pirtobrutinib monotherapy and BR treatments.
At a median follow-up of 28.1 months, pirtobrutinib demonstrated remarkable efficacy in improving progression-free survival (PFS), achieving a hazard ratio of 0.20 (95% CI, 0.11–0.37; p<0.0001), effectively highlighting its potential as a frontline therapy in this patient population.
Overall Survival Trends and Safety Profile
While overall survival (OS) remains an immature endpoint, early results suggest a favorable trend for pirtobrutinib (HR=0.257; 95% CI, 0.070–0.934; p=0.0261), despite a crossover of over 52.9% of patients in the BR group to pirtobrutinib after disease progression. These findings emphasize the promise of pirtobrutinib as a crucial therapeutic option.
Additionally, the safety profile of pirtobrutinib in the BRUIN CLL-313 trial was comparable to previous studies, with 40.0% of patients experiencing grade ≥3 treatment-emergent adverse events (TEAEs), compared to 67.4% in the BR group. This highlights its relative safety and tolerability.
Experts Weigh In
Dr. Wojciech Jurczak from the Maria Sklodowska-Curie National Research Institute of Oncology commented on the significance of these results, stating, "The results from BRUIN CLL-313 show a significant effect size, among the most pronounced ever observed for a single-agent BTK inhibitor in a front-line CLL study."
Jacob Van Naarden, Executive Vice President and President of Lilly Oncology, added, "These findings support the potential use of pirtobrutinib in certain treatment-naïve patients...We are hopeful we will receive regulatory approvals for pirtobrutinib in earlier disease settings sometime next year." This reflects Lilly's commitment to enhancing treatment options for CLL and SLL patients.
Implications and Future Directions
The promising results of the BRUIN CLL-313 trial suggest a transformative shift in the treatment landscape for patients with treatment-naïve CLL/SLL. Eli Lilly plans to submit these findings to regulatory authorities, aiming to expand the label for Jaypirca into earlier lines of therapy.
This pivotal study reinforces Lilly's position in the oncology market and signifies a potential breakthrough in managing chronic lymphocytic leukemia effectively. Ongoing studies continue to evaluate Jaypirca's efficacy across various scenarios, further solidifying its role in modern hematology.
About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib) is a selective BTK inhibitor, noted for being significantly more selective for BTK compared to other tested kinases. It is indicated for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have relapsed or are refractory to previous treatments. The drug is available in oral prescription form, allowing for convenient administration prior to disease progression or in the case of unacceptable toxicity.