Drug name: Nemtabrutinib
R&D code:ARQ531, MK1026
CAS:2095393-15-8
Indications:chronic lymphatic leukemia,small lymphocytic lymphoma
Originally developed by: Merck (developed by ArQule; in December 2019, Merck acquired ArQule)
Development stage: Phase 3
Merck launched the pivotal Phase 3 randomized BELLWAVE-011 research trial (NCT06136559) on November 18, 2023, to assess the effectiveness of Nemtabrutinib in patients with untreated CLL and SLL, compared to the investigator's choice of ibrutinib or acalabrutinib. Patients are being recruited for the trial on a global scale right now.
Aiming to enroll over 1,200 patients globally, BELLWAVE-011 is a global, randomized, open-label, active-comparison controlled Phase III clinical research. The study's primary objectives are progression-free survival (PFS) by 2018 iwCLL criteria as determined by BICR and objective remission rate (ORR) by 2018 chronic lymphocytic leukemia (iwCLL) criteria as determined by blinded independent center review (BICR). Overall survival (OS) and duration of response (DOR) by 2018 iwCLL criteria, as determined by BICR, were important secondary outcomes.
A Phase 3 study (BELLWAVE-008, NCT05624554) is presently being conducted in patients with SLL and CLL who have not had treatment before and do not have TP53 abnormalities, in addition to BELLWAVE-011.
