Lilly reveals 2024 ASH Annual Meeting presentation details

INDIANAPOLIS, Nov. 5, 2024 — Eli Lilly and Company (NYSE: LLY) announced that results from their studies on Jaypirca® (pirtobrutinib), a reversible Bruton's tyrosine kinase (BTK) inhibitor, will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition from Dec. 7-10 in San Diego.

The Phase 3 BRUIN CLL-321 study, evaluating pirtobrutinib against idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), will be highlighted in an oral presentation. The study previously met its primary endpoint, making it the first randomized Phase 3 study focusing on a population exclusively pretreated with BTK inhibitors. The abstract for this presentation was based on data until February 2024, while the on-site presentation will include data up to August 2024.

Additionally, Lilly will present several posters. One of them analyzes real-world treatment sequences and their impact on overall survival in CLL/SLL patients. Another poster details pre-clinical findings for LY4152199, a novel B-cell activating factor receptor (BAFF)-RxCD3 bispecific antibody aimed at treating specific B-cell malignancies.

Among the key presentations are:
- "BRUIN CLL-321: Randomized Phase 3 Trial of Pirtobrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma" by Jeff P. Sharman, scheduled for Dec. 9 at 3:30 p.m. PST.
- "Overall Survival Associated with Real-World Treatment Sequences in Patients with CLL/SLL in the United States" by Joanna Rhodes, on Dec. 9 from 6-8 p.m. PST.
- "Continuity of Care for Patients with Chronic Lymphocytic Leukemia: An Analysis of Real-World Data" by Sameh Gaballa, also on Dec. 9 from 6-8 p.m. PST.
- "LY4152199, a First-in-Class BAFF-RxCD3 Bispecific Antibody for the Treatment of B-Cell Malignancies" by Wei Yang, scheduled for Dec. 8 from 6-8 p.m. PST.

Jaypirca® (pirtobrutinib), previously known as LOXO-305, is a highly selective, reversible BTK inhibitor approved by the U.S. FDA. It targets BTK, a molecule present in multiple B-cell leukemias and lymphomas, including mantle cell lymphoma (MCL) and CLL/SLL. Jaypirca is administered as a 200 mg daily dose in tablet form.

Jaypirca is indicated for adult patients with relapsed or refractory MCL after at least two lines of systemic therapy, including a BTK inhibitor, and for adult patients with CLL/SLL who have had at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. These indications have received accelerated approval based on response rate, with continued approval pending further clinical benefit confirmation.

Important safety information for Jaypirca includes risks such as serious infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity, and embryo-fetal toxicity. The most common adverse reactions in the BRUIN pooled safety population included lowered neutrophil and hemoglobin counts, fatigue, musculoskeletal pain, and diarrhea, among others.

In clinical trials, serious adverse reactions for patients with MCL included pneumonia, COVID-19, and musculoskeletal pain. Fatal adverse reactions were also reported. For patients with CLL/SLL, serious adverse reactions included pneumonia, COVID-19, sepsis, and febrile neutropenia. Fatal adverse reactions were linked mainly to infections and sepsis.

Eli Lilly continues to focus on transforming patient care through innovative treatments and clinical trials that reflect global diversity. Their efforts in biotechnology, chemistry, and genetic medicine aim to address significant health challenges, including diabetes, obesity, Alzheimer's disease, immune system disorders, and cancer.