Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study.
Anthony R Mato, Nirav N Shah, Wojciech Jurczak, Chan Y Cheah, John M Pagel, Jennifer A Woyach, Bita Fakhri, Toby A Eyre, Nicole Lamanna, Manish R Patel, Alvaro Alencar, Ewa Lech-Maranda, William G Wierda, Catherine C Coombs, James N Gerson, Paolo Ghia, Steven Le Gouill, David John Lewis, Suchitra Sundaram, Jonathon B Cohen Show all
The Lancet | Published : 2021
BACKGROUND: Covalent Bruton's tyrosine kinase (BTK) inhibitors are efficacious in multiple B-cell malignancies, but patients discontinue these agents due to resistance and intolerance. We evaluated the safety and efficacy of pirtobrutinib (working name; formerly known as LOXO-305), a highly selective, reversible BTK inhibitor, in these patients. METHODS: Patients with previously treated B-cell malignancies were enrolled in a first-in-human, multicentre, open-label, phase 1/2 trial of the BTK inhibitor pirtobrutinib. The primary endpoint was the maximum tolerated dose (phase 1) and overall response rate (ORR; phase 2). This trial is registered with ClinicalTrials.gov, NCT03740529. FINDINGS: 3..View full abstract