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Loxo@Lilly Announces Details of Presentations at the 2022 American Society of Hematology Annual Meeting

2022-11-03

(PRNewsfoto/Eli Lilly and Company)

INDIANAPOLIS, Nov. 3, 2022 /PRNewswire/ -- [email protected], the oncology unit of Eli Lilly and Company (NYSE: LLY), today announced that study investigators will present data from the BRUIN Phase 1/2 trial of pirtobrutinib at the American Society of Hematology (ASH) Annual Meeting to be held December 10-13, 2022, in New Orleans, Louisiana, and virtually. Pirtobrutinib is an investigational, highly selective, potent, reversible inhibitor of the Bruton's tyrosine kinase (BTK).

The pirtobruEliiLilly and Company 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.Eli Lilly and Company pirtobrutinib Pirtobrutinib Bruton's tyrosine kinase (BTK)

Aboupirtobrutinibib (LOXO-305)chronic lymphocytic leukemia (CLL)small lymphocytic lymphoma (SLL)mantle cell lymphoma (MCL)Waldenström macroglobulinemia pirtobrutinib relapsed or refractory B-cell malignancies BTK CLL SLL Waldenström macroglobulinemia BTK

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 [email protected] Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Phase 1/2 Trial

Pirtobrutinibse 1/2 clinical trial is the ongoing first-in-human, global, multi-cBruton's tyrosine kinase (BTK) inhibitor Bruton's tyrosine kinase (BTK)nib in patieBTK previously treated for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL).BTK B-cell leukemias lymphomas chronic lymphocytic leukemia (CLL)mantle cell lymphoma (MCL)Waldenström macroglobulinemia Pirtobrutinib BTK BTK

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.

About Lillypirtobrutinib mantle cell lymphoma (MCL)chronic lymphocytic leukemia (CLL)small lymphocytic lymphoma (SLL)non-Hodgkin lymphomas (NHL)

Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram, Twitter and LinkedIn. P-LLY

Lilly Lillyrd-Looking Statement

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about pirtobrutinib for the potential treatment of previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, Richter transformation, and Waldenström macroglobulinemia and the timeline for future readouts, presentations, and other milestones relating to pirtobrutinib and itdiabetesal trials reflecobesityy's current beliefs and expectations. However, as with any pharmaceutical product, tAlzheimer's diseasel risks and uncertainties in the process of drug researimmune system disordersmercialization. Among other things, there is nocancerstee that studies will be completed as planned, that future study results will be consistent with the results to date, that pirtobrutinib will prove to be a safe and effective treatment for relevant indications, or that pirtobrutinib will receive regulatory approvals or be commercially successful. For further discussion ofLilly.comd other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Refer to:pirtobrutinib chronic lymphocytic leukemia small lymphocytic lymphoma mantle cell lymphoma Waldenström macroglobulinemia pirtobrutinib Lilly pirtobrutinib pirtobrutinib Lilly Lilly

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