Eli Lilly and Company will present data from studies of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 7-10. The presentations will include Phase 3 results, real-world data analyses, and pre-clinical findings.
BRUIN CLL-321 Phase 3 Trial Results
Lilly will report results from the Phase 3 BRUIN CLL-321 study in an oral presentation. This study evaluates pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor-pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The BRUIN CLL-321 study met its primary endpoint and is the first randomized Phase 3 study to evaluate an exclusively BTK inhibitor-pretreated CLL population. The presentation will utilize an August 2024 data cut-off date.
Real-World Data and Pre-Clinical Studies
Poster presentations will share analyses of real-world data, including overall survival associated with treatment sequences in patients with CLL/SLL, and pre-clinical data for a first-in-class B-cell activating factor receptor (BAFF)-RxCD3 bispecific antibody for the treatment of certain B-cell malignancies.
About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib) is a highly selective, non-covalent (reversible) inhibitor of the enzyme BTK. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Jaypirca is a U.S. FDA-approved oral prescription medicine, administered as a 200 mg dose once daily until disease progression or unacceptable toxicity.
Jaypirca Indications
Jaypirca is indicated for the treatment of:
- Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
- Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Safety Information
Jaypirca carries warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity, including drug-induced liver injury (DILI), and embryo-fetal toxicity.
