Loxo Oncology at Lilly Announces Publication of Pirtobrutinib (LOXO-305) Phase 1/2 Data in The Lancet
INDIANAPOLIS, March 5, 2021 /PRNewswire/ -- Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced that The Lancet has published data from the pirtobrutinib (previously referred to as LOXO-305) global Phase 1/2 BRUIN clinical trial in relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas. Pirtobrutinib is an investigational, highly selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor.
The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) Annual Meeting. The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström's macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020.
"Patients with B-cell malignancies who have been previously treated with the most commonly used regimens represent an area of growing and urgent unmet need", said Anthony Mato, M.D., director of the CLL Program at Memorial Sloan Kettering Cancer Center and lead author of The Lancet paper. "These data establish that the third generation BTK inhibitor pirtobrutinib possesses a compelling efficacy and safety profile with the potential to address this exact unmet need."
"While covalent BTK inhibitors and venetoclax have transformed the treatment of CLL, we now see many patients needing new therapeutic alternatives," said Brian Koffman, MDCM (retired), chief medical officer of the CLL Society. "In the coming years, we envision that this need will grow, and we are pleased to see data that pirtobrutinib may be a new option for these patients."
"We are extremely pleased to see the pirtobrutinib data from the ongoing Phase 1/2 BRUIN study published in The Lancet and shared with the broader clinical community", said David Hyman, M.D., chief medical officer of Loxo Oncology at Lilly. "The data to date from this study have continued to strengthen our conviction that pirtobrutinib has the potential to meaningfully improve the inadequate treatment options available to CLL and MCL patients who have been previously treated with the main treatment classes of today's standard of care. We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021."
In addition to the Phase 1/2 BRUIN clinical trial, Loxo Oncology at Lilly plans to initiate four global, randomized Phase 3 studies for pirtobrutinib in 2021, three in CLL and one in MCL.
About Pirtobrutinib (LOXO-305)
About the BRUIN Phase 1/2 Trial
About Loxo Oncology at Lilly
About Eli Lilly and Company
Disclosure: Dr. Mato has provided consulting and advisory services to Loxo Oncology at Lilly and Eli Lilly and Company.
Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about pirtobrutinib (LOXO-305) for the potential treatment of previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma and other non-Hodgkin lymphomas and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that studies will be initiated or completed as planned, that future study results will be consistent with the results to date, or that pirtobrutinib (LOXO-305) will receive regulatory approvals or be commercially successful. For further discussion of these and 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.
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