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Merck, known as MSD outside of the United States and Canada, announced that new data across multiple hematologic malignancies will be presented at the American Society of Haematology (ASH) Annual Meeting and Exposition in Orlando, Fla. from December 6-9. The data shared at the meeting will highlight the company’s ongoing commitment to advancing clinical research in haematology across Merck’s expanding and diverse pipeline of investigational candidates, with more than 20 abstracts being presented.
“The data we’re sharing at ASH 2025 reflect the continued growth and evolution of our promising haematology pipeline,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. “We continue to build on our leadership in oncology by advancing a diverse portfolio of investigational candidates and exploring novel modalities with the goal of improving outcomes and helping to address significant unmet needs for patients with hematologic neoplasms and malignancies.”
Data presentations will feature Merck’s pipeline candidates, including: MK-1045, an investigational CD19xCD3 T-cell engager; bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; and nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. Additionally, Merck will present new and updated results highlighting zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1).
Key data from Merck’s pipeline to be presented at the ASH 2025 Annual Meeting and Exposition:
- First presentation by Merck of updated results from the dose escalation and expansion portion of a phase 1b/2 study assessing the efficacy and safety of MK-1045 in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (Abstract #647)
- First-time results from the Phase 2 Shorespan-004 study evaluating bomedemstat for patients with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy (Abstract #83)
- Initial results from an exploratory analysis of the BELLWAVE-003 study of acquired resistance and prognostic mutations in patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) treated with nemtabrutinib (Abstract #797)
Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development programme that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic neoplasms and malignancies. Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies.
MK-1045 (previously CN201) is a novel, investigational CD19xCD3 T-cell engager, designed to redirect T-cells to specifically deplete malignant or pathogenic B cells. It is currently being evaluated in a phase 1 trial for the treatment of patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT06189391) and in a phase 1b/2 trial for patients with relapsed or refractory B-cell acute lymphocytic leukaemia (ALL) (NCT05579132).
Bomedemstat (MK-3543) is an investigational, orally available small molecule that inhibits lysine-specific demethylase 1 (LSD1), an enzyme that is potentially important for regulating the rapid reproduction of blood stem cells and the maturation of blood cells in the bone marrow. Bomedemstat is being studied across myeloproliferative neoplasms, including essential thrombocythemia, myelofibrosis and polycythemia vera. Two phase 3 trials are ongoing: Shorespan-006 (NCT06079879), an open-label study comparing bomedemstat to best available therapy in patients with essential thrombocythemia who have an inadequate response to or are intolerant of hydroxyurea, and Shorespan-007 (NCT06456346), a double-blind study evaluating bomedemstat versus hydroxyurea in patients with essential thrombocythemia who have not previously received cytoreductive therapy.
Nemtabrutinib is an investigational oral, reversible, non-covalent BTK inhibitor that suppresses oncogenic B-cell receptor signalling with activity against wild-type BTK and BTK pathway mutants. Nemtabrutinib aims to address a common mechanism of resistance with currently available covalent, BTK inhibitors by binding in an alternative way to the BTK protein. Merck is advancing research with nemtabrutinib across B-cell malignancies through its BELLWAVE clinical program. Two Phase 3 trials are ongoing: BELLWAVE-008 (NCT05624554), comparing nemtabrutinib to chemoimmunotherapy in previously untreated CLL/SLL without TP53 aberrations, and BELLWAVE-011 (NCT06136559), evaluating nemtabrutinib versus investigator’s choice of BTK inhibitors (ibrutinib or acalabrutinib) in previously untreated CLL/SLL.
Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and has established a robust programme of clinical trials under the name waveLINE. The waveLINE programme includes a Phase 3 study in patients with relapsed/refractory DLBCL (waveLINE-003, NCT05139017), a phase 3 study in patients with previously untreated DLBCL (waveLINE-010, NCT06717347), a phase 2 study in patients with select B-cell lymphomas (waveLINE-006, NCT05458297), a phase 2 study in patients with germinal center B-cell-like DLBCL (waveLINE-011, NCT06890884) and a phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401).
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