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Table 3 Clinical trials with non-covalent BTK inhibitors

From: Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies

Non-covalent BTK inhibitor Phase Patient population Strategy ClinicalTrials.gov ID Status
Vecabrutinib I/II dose escalation and expansion trial CLL/SLL or NHL (including LPL/WM, MCL, MZL, ABC-DLBCL, FL) patients who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication Monotherapy NCT03037645 Terminated
ARQ 531 I/II dose escalation and expansion trial Dose escalation cohorts: R/R CLL/SLL, FL, MCL, MZL, and WM patients who have received ≥ 2 prior systemic therapies; expansion cohorts include R/R CLL/SLL after ≥ 2 prior systemic therapies including a covalent BTKi, with or without a C481 mutation Monotherapy NCT03162536 Recruiting
Fenebrutinib Ia dose escalation trial R/R NHL (including FL, DLBCL, MCL, PLL/WM) or CLL Monotherapy NCT01991184 Active, not recruiting
LOXO-305 I/II dose escalation and expansion trial CLL/SLL or NHL patients who have failed or are intolerant to standard of care Monotherapy; combination therapy NCT03740529 Recruiting
LOXO-305 III MCL patients who have been previously treated with at least one prior line of systemic therapy and were BTK inhibitor naive Monotherapy (versus investigator choice of BTK Inhibitor) NCT04662255 Not yet recruiting
LOXO-305 III CLL/SLL patients who were previously treated with a covalent BTK inhibitor Monotherapy (versus idelalisib plus rituximab or bendamustine plus rituximab) NCT04666038 Not yet recruiting
  1. CLL/SLL chronic lymphocytic leukemia/small lymphocytic lymphoma, NHL non-Hodgkin's lymphoma, LPL lymphoplasmacytic lymphoma, WM Waldenstrom's macroglobulinemia, MCL mantle cell lymphoma, MZL marginal zone lymphoma, DLBCL diffuse large B cell lymphoma, ABC-DLBCL the activated B cell subtype of DLBCL, FL follicular lymphoma, BTK Bruton tyrosine kinase, R/R relapsed and/or refractory, PLL prolymphocytic leukemia