Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for LOXO-305 in Mantle Cell Lymphoma and Non-Hodgkin Lymphomas at the American Society of Hematology (ASH) Annual Meeting
Loxo Oncology at Lilly Announces Updated Data from the Phase 1/2 BRUIN Clinical Trial for LOXO-305 in Mantle Cell Lymphoma and Non-Hodgkin Lymphomas at the American Society of Hematology (ASH) Annual Meeting 52% overall response rate in mantle cell lymphoma patients previously treated with a covalent BTK inhibitor |
[05-December-2020] |
INDIANAPOLIS, Dec. 5, 2020 /PRNewswire/ -- Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced clinical data from the LOXO-305 global Phase 1/2 BRUIN clinical trial in mantle cell lymphoma (MCL) and other non-Hodgkin lymphomas. LOXO-305 is an investigational, highly selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor. These data are being presented in an oral presentation at the 2020 American Society of Hematology (ASH) Annual Meeting (abstract 117). "MCL patients who have been treated with a covalent BTK inhibitor have very few therapeutic options, and outcomes are extremely poor. LOXO-305 has demonstrated a promising efficacy profile in these patients, a setting where we urgently need new therapies," said Michael Wang, M.D., Puddin Clarke Endowed Professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center and presenting author. "I am also excited about the emerging data for LOXO-305 in other B-cell malignancies including Waldenström's macroglobulinemia." "We are very excited to share this update on LOXO-305 in MCL with the hematology community and look forward to sharing data on chronic lymphocytic leukemia and small lymphocytic lymphoma patients in the coming days," said David Hyman, M.D., chief medical officer of Loxo Oncology at Lilly. "LOXO-305 was designed to overcome some of the limitations seen with current BTK therapies and we believe the promising efficacy and tolerability data demonstrate its potential to be an important new treatment option for MCL patients. In addition, we look forward to initiating an ambitious Phase 3 study in MCL patients early next year where we aim to demonstrate superiority of LOXO-305 against covalent BTK inhibitors." Additional data from the BRUIN Phase 1/2 trial in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) will be presented in an oral presentation at ASH (abstract 542) on Monday, December 7 at 10a.m. ET/7a.m. PT. Key Data Presented at ASH As of September 27, 2020, 323 patients were enrolled in the study, including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström's macroglobulinemia (WM), and 66 with other B-cell lymphomas. The 61 patients with MCL received a median of three prior lines of therapy, with 93% receiving a prior BTK inhibitor, 98% an anti-CD20 antibody, 92% chemotherapy, 20% lenalidomide, 25% autologous transplant, 5% CAR-T cell therapy, and 5% allogeneic transplant. Pharmacokinetic analyses during dose escalation demonstrated consistent dose-proportional exposures with low inter-patient variability across the entire dosing range of 25mg to 300mg daily. Doses of 100mg QD and greater exceeded BTK IC90 target coverage for the entirety of the dosing interval. Responses were observed starting at the first dose level. The efficacy data presented at ASH are based on investigator response assessments. Patients were considered efficacy-evaluable if they had at least one post-baseline response assessment or if they discontinued treatment prior to their first post-baseline response assessment.
Safety data were presented for the entire enrolled BRUIN population. Across all 323 patients enrolled in the study, the most commonly reported adverse events, regardless of attribution, were fatigue (20%), diarrhea (17%), and contusion (13%). In addition, rates of two adverse events commonly associated with BTK inhibitors, atrial arrythmias and hemorrhage, were low, experienced by two patients and one patient respectively, and considered by investigators as unrelated to LOXO-305. Dose interruptions, reductions and permanent discontinuations for drug-related adverse events were observed in 8%, 2.2%, and 1.5% of patients, respectively. No dose limiting toxicities were reported and a maximum tolerated dose (MTD) was not reached. LOXO-305 Development Program Update Loxo Oncology at Lilly is preparing to initiate a global, randomized, superiority Phase 3 clinical trial to study LOXO-305 versus currently available covalent BTK inhibitors in BTK treatment naïve patients with relapsed-refractory MCL. Participants will be randomized to receive either LOXO-305 monotherapy or investigator's choice of ibrutinib, acalabrutinib or zanubrutinib. The trial, BRUIN MCL-321, is expected to begin in the first quarter of 2021. About LOXO-305 About the BRUIN Trial About Loxo Oncology at Lilly About Eli Lilly and Company This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly's LOXO-305 for the potential treatment of previously treated chronic lymphocytic leukemia, small lymphocytic lymphoma and non-Hodgkin lymphoma and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that studies will complete as planned, that future study results will be consistent with the results to date, or that 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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