Eli Lilly Set to Showcase Key Findings on Jaypirca at ASH 2025 Annual Meeting
Eli Lilly and Company is gearing up to present pivotal findings on Jaypirca (pirtobrutinib) at the upcoming 67th Annual Meeting of the American Society of Hematology (ASH) scheduled for December 6-9, 2025, in Orlando, Florida. This year's meeting marks a key opportunity for Lilly to showcase the outcomes of two significant Phase 3 studies, BRUIN CLL-314 and BRUIN CLL-313, which assess the efficacy of Jaypirca in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Overview of the Presentations
The BRUIN CLL-314 study is notable as it compares the effectiveness of Jaypirca against Imbruvica (ibrutinib), representing the first-ever head-to-head Phase 3 study that includes treatment-naïve CLL/SLL patients. Results from this study showed that Jaypirca achieved a non-inferiority response rate, demonstrating promising results with a nominal P-value for superiority lower than 0.05. This innovative research is critical as it paves the way for further discussion on the treatment landscape of CLL/SLL during the December meeting.
In addition to the findings from BRUIN CLL-314, Lilly will also present late-breaking results from the BRUIN CLL-313 study. This study highlights the performance of pirtobrutinib against chemoimmunotherapy in a patient cohort with treatment-naïve CLL/SLL lacking the del(17p) chromosomal alteration. Notably, the study demonstrated a significant and clinically relevant improvement in progression-free survival when using Jaypirca compared to traditional methodologies. These results will be discussed in a dedicated session on December 8.
Long-term Efficacy and Safety Data
Further building on its groundwork, Lilly will share additional data regarding the effectiveness and safety of Jaypirca through interim analyses from the Phase 1/2 BRUIN study. This study focused on patients experiencing relapsed or refractory CLL, mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM), with crucial long-term data signaling approximately five years of follow-up. The data emphasizes the drug's robust clinical profile and reinforces its potential applicability across treatment settings for various B-cell malignancies.
Moreover, Lilly will present an investigator-initiated Phase 2 study examining a time-limited treatment regimen combining pirtobrutinib, venetoclax, and obinutuzumab in previously untreated CLL patients.
"As we present full results on the Phase 3 studies, we are enthusiastic about sharing the insights gathered from our comprehensive investigations into pirtobrutinib's role in treating these challenging malignancies," expressed Jacob Van Naarden, Executive Vice President and President of Lilly Oncology. "These collective findings underline the unique therapeutic profile of Jaypirca and its potential to revolutionize treatment practices within hematology."
What is Jaypirca?
Jaypirca (pirtobrutinib) is recognized as a highly selective and non-covalent Bruton tyrosine kinase (BTK) inhibitor, taking a novel approach to combating various B-cell leukemias and lymphomas. It is currently FDA-approved for adults with relapsed or refractory MCL after at least two lines of systemic therapy and for CLL/SLL patients who have undergone two prior treatment lines including BTK inhibitors and BCL-2 inhibitors.
This promising development comes with an essential note regarding patient safety. Jaypirca could potentially induce severe adverse reactions, including infections and cytopenias. Thus, patient monitoring during the treatment process is paramount. Lilly advocates for healthcare professionals to employ vigilant monitoring and management strategies as they navigate the complexities associated with treating hematologic malignancies.
In summary, Eli Lilly's presentations at ASH 2025 is not just a platform for unveiling statistical findings; it symbolizes a significant step forward in the commitment to innovate hematologic treatment and provide patients with effective therapeutic options. The full details will undoubtedly propel discussions and advance understanding of chronic lymphocytic leukemia management in the coming years.
Overview of the Presentations
The BRUIN CLL-314 study is notable as it compares the effectiveness of Jaypirca against Imbruvica (ibrutinib), representing the first-ever head-to-head Phase 3 study that includes treatment-naïve CLL/SLL patients. Results from this study showed that Jaypirca achieved a non-inferiority response rate, demonstrating promising results with a nominal P-value for superiority lower than 0.05. This innovative research is critical as it paves the way for further discussion on the treatment landscape of CLL/SLL during the December meeting.
In addition to the findings from BRUIN CLL-314, Lilly will also present late-breaking results from the BRUIN CLL-313 study. This study highlights the performance of pirtobrutinib against chemoimmunotherapy in a patient cohort with treatment-naïve CLL/SLL lacking the del(17p) chromosomal alteration. Notably, the study demonstrated a significant and clinically relevant improvement in progression-free survival when using Jaypirca compared to traditional methodologies. These results will be discussed in a dedicated session on December 8.
Long-term Efficacy and Safety Data
Further building on its groundwork, Lilly will share additional data regarding the effectiveness and safety of Jaypirca through interim analyses from the Phase 1/2 BRUIN study. This study focused on patients experiencing relapsed or refractory CLL, mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM), with crucial long-term data signaling approximately five years of follow-up. The data emphasizes the drug's robust clinical profile and reinforces its potential applicability across treatment settings for various B-cell malignancies.
Moreover, Lilly will present an investigator-initiated Phase 2 study examining a time-limited treatment regimen combining pirtobrutinib, venetoclax, and obinutuzumab in previously untreated CLL patients.
"As we present full results on the Phase 3 studies, we are enthusiastic about sharing the insights gathered from our comprehensive investigations into pirtobrutinib's role in treating these challenging malignancies," expressed Jacob Van Naarden, Executive Vice President and President of Lilly Oncology. "These collective findings underline the unique therapeutic profile of Jaypirca and its potential to revolutionize treatment practices within hematology."
What is Jaypirca?
Jaypirca (pirtobrutinib) is recognized as a highly selective and non-covalent Bruton tyrosine kinase (BTK) inhibitor, taking a novel approach to combating various B-cell leukemias and lymphomas. It is currently FDA-approved for adults with relapsed or refractory MCL after at least two lines of systemic therapy and for CLL/SLL patients who have undergone two prior treatment lines including BTK inhibitors and BCL-2 inhibitors.
This promising development comes with an essential note regarding patient safety. Jaypirca could potentially induce severe adverse reactions, including infections and cytopenias. Thus, patient monitoring during the treatment process is paramount. Lilly advocates for healthcare professionals to employ vigilant monitoring and management strategies as they navigate the complexities associated with treating hematologic malignancies.
In summary, Eli Lilly's presentations at ASH 2025 is not just a platform for unveiling statistical findings; it symbolizes a significant step forward in the commitment to innovate hematologic treatment and provide patients with effective therapeutic options. The full details will undoubtedly propel discussions and advance understanding of chronic lymphocytic leukemia management in the coming years.
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