Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study

AR Mato; NN Shah; W Jurczak; CY Cheah; JM Pagel; JA Woyach; B Fakhri; TA Eyre; N Lamanna; MR Patel; A Alencar; E Lech-Maranda; WG Wierda; CC Coombs; JN Gerson; P Ghia; S Le Gouill; DJ Lewis; S Sundaram; JB Cohen; IW Flinn; CS Tam; MA Barve; B Kuss; J Taylor; O Abdel-Wahab; SJ Schuster; ML Palomba; KL Lewis; LE Roeker; MS Davids; XN Tan; TS Fenske; J Wallin; DE Tsai; NC Ku; E Zhu; J Chen; M Yin; B Nair; K Ebata; N Marella; JR Brown; M Wang

Journal article

Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study

AR Mato, NN Shah, W Jurczak, CY Cheah, JM Pagel, JA Woyach, B Fakhri, TA Eyre, N Lamanna, MR Patel, A Alencar, E Lech-Maranda, WG Wierda, CC Coombs, JN Gerson, P Ghia, S Le Gouill, DJ Lewis, S Sundaram, JB Cohen Show all

Lancet | Published : 2021

DOI: 10.1016/S0140-6736(21)00224-5

Abstract

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..

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