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GSK plc will present new data from its haematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition (6 - 9 December), reinforcing its potential to redefine outcomes for patients with difficult-to-treat blood cancers.
New results from the DREAMM programme for belantamab mafodotin further support its potential to extend remission in relapsed or refractory multiple myeloma, with development in newly diagnosed patients underway
Key presentations include:
• Updated results from DREAMM-8 (median 35.8 months of follow-up) explore depth of response and sustained benefit for patients with relapsed or refractory multiple myeloma (Abstract #2264)
• DREAMM-7 post hoc analysis explores patient characteristics and outcomes associated with duration and depth of response in responders with progression-free survival (PFS) greater than three years (Abstract #2262)
• Combined DREAMM-7 and DREAMM-8 subgroup analysis evaluates PFS 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, a population with typically poor outcomes (Abstract #5820)
• Analyses from DREAMM-9 in transplant-ineligible newly diagnosed multiple myeloma patients assess the potential for higher initial dose intensity to optimise response, followed by dosing schedule extensions to minimise the potential for eye-related side effects (Abstract #5840)
New analyses for momelotinib build on positive MOMENTUM and SIMPLIFY trial results, assessing spleen and anaemia endpoints alongside overall survival, and early results from a first combination trial will be presented.
Additional analyses from MOMENTUM and SIMPLIFY-1 highlight the ability of momelotinib to improve haemoglobin levels and achieve a dual response — both transfusion independence and spleen volume reduction — and the association of these outcomes with survival outcomes in myelofibrosis patients with or without prior JAK inhibitor therapy. (Abstract #2023)
Preliminary efficacy and safety results will be shared from the ODYSSEY trial — the first combination trial for momelotinib evaluating it in combination with luspatercept. The trial explores whether momelotinib’s unique dual mechanism, targeting both anaemia and splenomegaly, can serve as a foundational backbone in future combination therapies to deliver deeper, more durable responses. (Abstract #3803).
Additional presentations include:
• Post hoc analysis from the MOMENTUM trial assesses the association between increased momelotinib exposure and greater anaemia-related benefits in patients previously treated with JAK inhibitors (Abstract #5580)
• Analyses show momelotinib survival results in intermediate- and high-risk patients as defined by the RR6 model following switch from ruxolitinib, a standard of care, at or before 6 months (Abstract #5579)
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately 180,000 new cases of multiple myeloma 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 centre.
Myelofibrosis 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 signalling. The clinical hallmarks of myelofibrosis are splenomegaly (enlarged spleen), severely low blood counts, including anaemia and thrombocytopenia, and debilitating constitutional symptoms, such as fatigue, night sweats and bone pain, attributable to ineffective haematopoiesis and excessive production of proinflammatory cytokines.
Belantamab mafodotin is a monoclonal ADC (antibody-drug conjugate) comprising a humanised BCMA (B-cell maturation antigen) conjugated to the cytotoxic agent monomethyl auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.
In October 2025, the US FDA approved10 belantamab mafodotin under the brand name Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Belantamab mafodotin in combination with bortezomib and dexamethasone and belantamab mafodotin in combination with pomalidomide and dexamethasone are approved in 2L+ relapsed or refractory multiple myeloma in the European Union, UK, Japan, Canada, Switzerland and Brazil.
Applications are currently under review in other markets globally, including China where the application is based on the results of DREAMM-7 and has been granted Breakthrough Therapy Designation and Priority Review.
In the US, Blenrep is indicated in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1). Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly. Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia-related benefit.
In September 2023, the US Food and Drug Administration approved momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anaemia.
In January 2024, the European Commission granted marketing authorisation for momelotinib for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Momelotinib was also approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to treat the symptoms experienced by adult myelofibrosis patients who have moderate or severe anaemia.
In June 2024, the Japan Ministry of Health, Labour and Welfare (MHLW) approved momelotinib for the treatment of myelofibrosis. Momelotinib is currently approved in 21 countries and applications are under review in other markets globally.
Momelotinib is indicated for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
GSK’s ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor.
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.
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