On November 3, 2022 Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), reported that study investigators will present data from the BRUIN Phase 1/2 trial of pirtobrutinib at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, Louisiana, and virtually (Press release, Eli Lilly, NOV 3, 2022, View Source [SID1234623058]). Pirtobrutinib is an investigational, highly selective, potent, reversible inhibitor of the Bruton’s tyrosine kinase (BTK).
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The pirtobrutinib oral and poster presentations will provide updated clinical data from the ongoing BRUIN Phase 1/2 study in previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Richter transformation, and Waldenström macroglobulinemia. In addition, an analysis of the safety and tolerability of pirtobrutinib monotherapy in patients with relapsed or refractory B-cell malignancies who were intolerant to a prior covalent BTK inhibitor will be presented in a poster presentation. Submitted abstracts on CLL/SLL, Richter transformation, Waldenström macroglobulinemia, and intolerance to prior covalent BTK therapy utilized a January 2022 data cut-off date, and the presentations will utilize a July 2022 data cut-off date.
A list of the presentations, along with their viewing details, is shared below.
Presentation Title
Details
Efficacy of Pirtobrutinib, a Highly Selective,
Non-Covalent (Reversible) BTK Inhibitor in
Relapsed / Refractory Waldenström
Macroglobulinemia: Results from the Phase 1/2
BRUIN Study
Abstract #229
Oral Session: 623. Mantle Cell, Follicular, and
Other Indolent B Cell Lymphomas:
Clinical and Epidemiological III
Date: Saturday, December 10, 2022
Presentation Time: 2:00 PM CT
Location: Theater C
Presenter: M. Lia Palomba, M.D.
Efficacy of Pirtobrutinib, a Highly Selective,
Non-Covalent (Reversible) BTK Inhibitor in
Richter Transformation: Results from the Phase
1/2 BRUIN Study
Abstract #347
Oral Session: 642. Chronic Lymphocytic
Leukemia: Clinical and Epidemiological:
Targeted Triplet Combinations and Richter’s
Transformation
Date: Saturday, December 10, 2022
Presentation Time: 5:00 PM CT
Location: R06-R09
Presenter: William G. Wierda, M.D., Ph.D.
Efficacy of Pirtobrutinib in Covalent BTK-
inhibitor Pre-treated Relapsed / Refractory
CLL/SLL: Additional Patients and Extended
Follow-up from the Phase 1/2 BRUIN Study
Abstract #961
Oral Session: 642. Chronic Lymphocytic
Leukemia: Clinical and Epidemiological: Drugs
in Development and COVID-19
Date: Monday, December 12, 2022
Presentation Time: 4:30 PM CT
Location: 243-245
Presenter: Anthony R. Mato, M.D.
Safety and Tolerability of Pirtobrutinib
Monotherapy in Patients with B-Cell
Malignancies Who Were Previously Intolerant
to a Covalent BTK Inhibitor: Results from the
Phase 1/2 BRUIN Study
Abstract #1797
Poster Session: 642. Chronic Lymphocytic
Leukemia: Clinical and Epidemiological:
Poster I
Date: Saturday, December 10, 2022
Time: 5:30 PM – 7:30 PM CT
Location: Hall D
Presenter: Nirav N. Shah, M.D.
Efficacy of Pirtobrutinib in Covalent BTK-
inhibitor Pre-treated Relapsed / Refractory
Mantle Cell Lymphoma: Additional Patients and
Extended Follow-up from the Phase 1/2
BRUIN Study
Abstract #4218
Poster Session: 623. Mantle Cell, Follicular, and
Other Indolent B Cell Lymphomas:
Clinical and Epidemiological: Poster III
Date: Monday, December 12, 2022
Time: 6:00 PM – 8:00 PM CT
Location: Hall D
Presenter: Michael L. Wang, M.D.
About Pirtobrutinib (LOXO-305)
Pirtobrutinib is an investigational, highly selective, reversible (non-covalent) Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia. Pirtobrutinib was developed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, and preserve activity in the presence of the C481 acquired resistance mutations. Interested patients and physicians can contact the Loxo@Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].
About the BRUIN Phase 1/2 Trial
The BRUIN Phase 1/2 clinical trial is the ongoing first-in-human, global, multi-center evaluation of pirtobrutinib in patients previously treated for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL).
The trial includes a Phase 1 dose-escalation phase, a Phase 1b combination arm, and a Phase 2 dose-expansion phase. The primary endpoint of the Phase 1/1b study is safety, and secondary endpoints include pharmacokinetics and preliminary efficacy of the drug combinations. The primary endpoint for Phase 2 is overall response rate. Secondary endpoints include duration of response, overall survival, safety, and pharmacokinetics.