GSK Presents Long-Term Data Supporting Belantamab Mafodotin and Momelotinib for Blood Cancers at ASH 2024
核心洞察
GSK will present new long-term data from DREAMM-7 and DREAMM-8 studies at ASH 2024, highlighting sustained benefits of belantamab mafodotin in relapsed or refractory multiple myeloma (搜索) patients.
Updated analyses from MOMENTUM and SIMPLIFY-1 trials reinforce momelotinib's potential in achieving spleen and anemia benefits associated with survival outcomes in myelofibrosis (搜索) patients.
The DREAMM-9 study evaluates an optimal dosing schedule for belantamab mafodotin in newly diagnosed multiple myeloma (搜索), while ODYSSEY represents the first combination trial for momelotinib with luspatercept.
GSK will present compelling new data from its hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, showcasing the potential of belantamab mafodotin and momelotinib to transform treatment outcomes for patients with difficult-to-treat blood cancers.
Long-Term DREAMM Program Results Demonstrate Sustained Benefits
The DREAMM program continues to yield promising results for belantamab mafodotin in multiple myeloma (搜索) treatment. Updated results from DREAMM-8, with a median follow-up of 35.8 months, will explore depth of response and sustained benefit for patients with relapsed or refractory multiple myeloma. The presentation will examine patient characteristics and outcomes associated with duration and depth of response in responders with progression-free survival greater than three years.
A combined DREAMM-7 and DREAMM-8 subgroup analysis will evaluate progression-free survival and minimal residual disease negativity rates following treatment with belantamab mafodotin versus standard of care therapies in patients with functional high-risk relapsed or refractory multiple myeloma (搜索), a population with typically poor outcomes.
Expanding Into Newly Diagnosed Multiple Myeloma
The DREAMM-9 study marks an important expansion into newly diagnosed multiple myeloma (搜索) patients who are transplant-ineligible. This trial assesses the potential for higher initial dose intensity to optimize response, followed by dosing schedule extensions to minimize the potential for eye-related side effects.
Momelotinib Data Reinforces Dual Benefits in Myelofibrosis
Additional analyses from the MOMENTUM and SIMPLIFY-1 trials highlight momelotinib's ability to improve hemoglobin levels and achieve a dual response—both transfusion independence and spleen volume reduction—and the association of these outcomes with survival outcomes in myelofibrosis (搜索) patients with or without prior JAK inhibitor therapy.
The ODYSSEY trial represents a significant milestone as the first combination trial for momelotinib, evaluating it in combination with luspatercept. The trial explores whether momelotinib's unique dual mechanism, targeting both anemia and splenomegaly, can serve as a foundational backbone in future combination therapies to deliver deeper, more durable responses.
Regulatory Approvals and Market Expansion
Belantamab mafodotin received FDA approval in October 2025 under the brand name Blenrep in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (搜索) who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. The drug is also approved in the European Union, UK, Japan, Canada, Switzerland and Brazil, with applications under review in other markets globally, including China where it has been granted Breakthrough Therapy Designation and Priority Review.
Momelotinib, marketed as Ojjaara, received FDA approval in September 2023 for the treatment of intermediate or high-risk myelofibrosis (搜索) in adults with anemia. The European Commission granted marketing authorization in January 2024, and the drug was approved by the UK's MHRA and Japan's MHLW in 2024. Momelotinib is currently approved in 21 countries with applications under review in other markets globally.
Addressing Significant Unmet Medical Needs
Multiple myeloma (搜索) is the third most common blood cancer globally and is generally considered treatable but not curable, with approximately 180,000 new cases diagnosed globally each year. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. Many patients with multiple myeloma, including approximately 70% in the US, are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic center.
Myelofibrosis (搜索) is a rare blood cancer that disrupts the body's normal production of blood cells because of dysregulated JAK-signal transducer and activator of transcription protein signaling. The clinical hallmarks of myelofibrosis are splenomegaly, severely low blood counts including anemia and thrombocytopenia, and debilitating constitutional symptoms such as fatigue, night sweats and bone pain.
Differentiated Mechanisms of Action
Belantamab mafodotin is a monoclonal antibody-drug conjugate comprising a humanized BCMA (搜索) conjugated to the cytotoxic agent monomethyl auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc (搜索)., while the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc (搜索)., a member of the Kyowa Kirin Group.
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signaling pathways: Janus kinase (JAK) 1, JAK2 (搜索), and activin A receptor, type I (ACVR1 (搜索)). Inhibition of JAK1 (搜索) and JAK2 may improve constitutional symptoms and splenomegaly, while inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anemia-related benefit.