Page 109 - Haematologica Vol. 110 - January 2025

ARTICLE - Pirtobrutinib in patients with prior intolerance to BTKi N.N. Shah et al.
ma, Epizyme, Fate Therapeutics, Forma Therapeutics, Forty Seven, Genentech, Gilead Sciences, InnoCare Pharma, IGM Biosciences, Incyte, Infinity Pharmaceuticals, Janssen, Kite Pharma, Loxo Oncology, Marker Therapeutics, Merck, Millen- nium Pharmaceuticals, MorphoSys, Myeloid Therapeutics, Novartis, Nurix, Pfizer, Pharmacyclics, Portola Pharmaceu- ticals, Rhizen Pharmaceuticals, Roche, Seattle Genetics, Step Pharma, Tessa Therapeutics, TG Therapeutics, Trillium Therapeutics, Triphase Research & Development Corp., Un- um Therapeutics, Verastem, Vincerx Pharma, 2seventy bio, Genmab. SM - Abbvie, AstraZeneca, BeiGene, Loxo Oncology, Juno, BMS, Janssen, Eli Lilly and Company. CCC - AbbVie, AstraZeneca, Beigene, Genentech, Janssen, MEI Pharma, TG Therapeutics, Octapharma, Allogene, Eli Lilly and Company Pfizer, Bluebird Bio. CYC - Roche, Janssen, Gilead, AstraZen- eca, Beigene, Menarini, Dizal, Abbvie, Genmab, BMS, Abbvie; MSD, Eli Lilly and Company. BF - Abbvie, ADC Therapeutics, Astrazeneca, BeiGene, BMS/Juno, Genentech, Genmab/ Abbvie, Loxo Oncology, Pharmacyclics. WSK - Sanofi, Kyo- wa-Kirin, Roche, Boryung, Donga, BeiGene. MAB - Tempus Labs, Texas Oncology. JBC - Loxo Oncology, Takeda, Novar- tis, BMS/Celgene, Genentech, AstraZeneca, BioInvent, Lam Therapeutics, Beigene, Janssen, Abbvie, ADCT. WJ - Eli Lilly and Company. TM - Eli Lilly and Company, Roche, Abbvie, AstraZeneca, Janssen, Sobi, BeiGene. MCT - Abbvie, Astra- Zeneca, BeiGene, GenMab, Nurix Therapeutics, Jannsen, Loxo Oncology, Dava Oncology, Philips Group Oncology Commu- nications, MJH Life Sciences, Intellisphere LLC, PeerView Institute for Medical Education, Massachusetts Medical Society, Brazilian Association of Hematology, Hemotherapy and Cellular Therapy (ABHH), Massachusetts Medical So- ciety. JRB - BeiGene, Gilead, iOnctura, Loxo Oncology, MEI Pharma, SecuraBio, and TG Therapeutics, UpToDate, Abbvie, Acerta/AstraZeneca, Alloplex Biotherapeutics, Bristol Myers Squibb, Galapagos NV, Genentech/Roche, Grifols Worldwide Operations, Hutchmed, InnoCare Pharma Inc, Janssen, Kite Pharma, Merck, Numab Therapeutics, Pfizer, Pharmacyclics, Grifols Therapeutics. LER, WGW, CCC, MAB and JRB report other financial or non-financial interests, stock or stock options, royalties or licenses. DET, KB, NAC, JFK, RAW and HH were full-time employees of Loxo Oncology during the conduct of the study. ASR was a full-time employee of Eli Lilly and Company during the conduct of the study. JNG and ELM have no conflicts of interest to disclose.
References
1. Lewis KL, Cheah CY. Non-covalent BTK inhibitors-the new BTKids on the block for B-cell malignancies. J Pers Med. 2021;11(8):764.
2. Lipsky A, Lamanna N. Managing toxicities of Bruton tyrosine kinase inhibitors. Hematology Am Soc Hematol Educ Program. 2020;2020(1):336-345.
3. Mato AR, Nabhan C, Thompson MC, et al. Toxicities and
Contributions
WGW, IF and JRB are responsible for study concept and design. NNS, MW, LER, KP, JAW WGW, CSU, TAE, PLZ, AJA, NL, MSH, MRP, JNG, SM, CCC, CYC, ELM, BF, WSK JBC, WJ, TM and JRB acquired study data. NNS, MW, KP, JAW, WGW, CSU, TAE, AJA, PG, NL, MSH, MRP, IF, SM, CCC, BF, MAB, JBC, WJ, MCT and JRB analyzed and interpreted the study data. DET, KB, NAC, JFK, RAW, HH and ASR verified and interpreted the acquired study data, and carried out the analysis. ASR conducted statistical analyses. All authors vouch for the completeness and accuracy of the data and adherence to the protocol. All authors critically revised the manuscript and approved the final version.
Acknowledgments
We thank the patients, their families, and the trial teams at the participating centers.
Funding
The BRUIN trial is supported by funding from Loxo Oncol- ogy, a wholly owned subsidiary of Eli Lilly and Company. Institutional expenses incurred during the study were also supported in part by National Institutes of Health / Na- tional Cancer Institute Cancer Center support grant P30 CA008748. Medical writing support was provided by Eli Lilly and Company.
Data-sharing statement
Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request six months after the indication studied has been approved in the US and EU, and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data-shar- ing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at: www.vivli.org/ ourmember/lilly/
outcomes of 616 ibrutinib-treated patients in the United States:
a real-world analysis. Haematologica. 2018;103(5):874-879. 4. Roeker LE, DerSarkissian M, Ryan K, et al. Real-world
comparative effectiveness of acalabrutinib and ibrutinib in patients with chronic lymphocytic leukemia. Blood Adv. 2023;7(16):4291-4301.
5. UK CLL Forum. Ibrutinib for relapsed/refractory chronic
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