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Therapy Name | ARQ 531 |
Synonyms | |
Therapy Description |
ARQ 531 is an ATP-competitive BTK inhibitor with activity against wild-type BTK and BTK C481S, which may inhibit migration and viability of tumor cells (PMID: 30093506, PMID: 31992353). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
ARQ 531 | ARQ531|ARQ-531|Nemtabrutinib|MK-1026|MK 1026|MK1026 | BTK inhibitor 37 | ARQ 531 is an ATP-competitive BTK inhibitor with activity against wild-type BTK and BTK C481S, which may inhibit migration and viability of tumor cells (PMID: 30093506, PMID: 31992353). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
FLT3 exon 14 ins | acute myeloid leukemia | not predictive | ARQ 531 | Preclinical - Patient cell culture | Actionable | In a preclinical study, ARQ 531 treatment induced apoptosis in acute myeloid leukemia cells harboring either FLT3 exon 14 insertion (FLT3-ITD) or wild-type FLT3, and inhibited proliferation and reduced colony formation in patient cells derived from acute myeloid leukemia independent of FLT3 status in culture (PMID: 31992353). | 31992353 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT06136559 | Phase III | Ibrutinib ARQ 531 Acalabrutinib | A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) | Recruiting | USA | TUR | SWE | POL | NZL | NOR | ISR | GRC | GBR | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | 11 |
NCT04728893 | Phase II | ARQ 531 | Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) | Recruiting | USA | TUR | ROU | POL | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | AUS | ARG | 3 |
NCT03162536 | Phase I | ARQ 531 | Safety, PK, PD, and Antitumor Activity of ARQ 531 in Hematologic Malignancies | Active, not recruiting | USA | 0 |
NCT05624554 | Phase III | Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab ARQ 531 | A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) | Recruiting | USA | TUR | ROU | POL | LTU | HUN | DNK | BRA | BGR | AUS | 11 |