Moving Belantamab Mafodotin to Newly Diagnosed Myeloma?

Belantamab mafodotin (belamaf, Blenrep, GSK) combinations were recently re-approved by the UK’s MHRA for relapsed or refractory multiple myeloma, and the FDA is anticipated to make a decision by July 2025. 

Beyond its use in relapsed or refractory cases, could a belamaf combination be safe and effective for newly diagnosed myeloma patients who aren’t able to receive an autologous stem cell transplant? 

Continue reading to learn findings from the DREAMM-9 trial! 

What is belamaf?

Belamaf is a type of targeted therapy known as an antibody-drug conjugate. It works by attaching to a protein called BCMA found on myeloma cells. Once attached, it delivers a cell-killing substance directly into the cancer cell. This approach is designed to reduce damage to healthy cells. 

Learn More About Belamaf in HealthTree University

How is belamaf being evaluated for newly diagnosed myeloma patients?

The DREAMM-9 study looked at different doses and schedules of belamaf when added to the standard treatment for patients who could not receive a stem cell transplant. This standard therapy includes bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone, often called VRd. After eight 21-day treatment cycles, bortezomib was stopped, and maintenance therapy continued with belamaf and Rd (lenalidomide and dexamethasone). 

The goal was to find a balance between effectiveness and tolerability, especially for those who could not handle high-intensity treatment. By lowering the dose and spacing out how often patients received it, researchers aimed to reduce side effects while keeping the therapy effective. 

What do the results show so far?

At the data cut-off in March 2024, 108 patients were enrolled across 8 study groups. Each group received a different belamaf dose and treatment frequency. The average patient age was 74, 46% were women, and 15% had high-risk myeloma features. 

At the check-in point (varied for each group from 7.8 to 37.6 months):

• Overall response rate (ORR): Ranged from 71% to 100% depending on the group
• Very good partial response (VGPR) or better: Reached 100% in 3 of the groups
• Complete response (CR) or better: Seen in 30% to 92% of patients across groups
• Minimal residual disease (MRD) negativity: Ranged from 0% to 75% among groups and continued to increase during the maintenance phase

Certain treatment groups began at different times, so some had not been on therapy long enough to show a full response. As more time passes, researchers will better understand how effective the treatment is across all groups.

How were side effects managed?

Belamaf-related side effects that required hospital care (grade 3/4) were reported in 33% of patients. These included low platelet levels (thrombocytopenia), low white blood cell counts (neutropenia), COVID-19 pneumonia, and eye irritation (keratopathy).

These decreased with lower belamaf doses, more space between treatment administrations, and during the maintenance phase. If you have questions about how treatment-related side effects are managed, please consult with your myeloma specialist. 

Key takeaways 

In the DREAMM-9 trial, belamaf plus VRd showed high response rates in people with newly diagnosed multiple myeloma who were unable to receive a stem cell transplant. Side effects were manageable with lower and less frequent dosing. 

The next step in evaluating belamaf for newly diagnosed myeloma patients takes place in the recruiting phase 3 DREAMM-10 trial. In the study, patients will receive either belamaf with Rd or daratumumab with Rd. The findings will help determine belamaf’s best use as a first-line myeloma treatment. 

Continue Reading Myeloma News

Source: 

• Phase I Study of Belantamab Mafodotin in Combination with Standard of Care in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: DREAMM-9 Updated Interim Analysis