All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.
The Multiple Myeloma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Introducing
Now you can personalise
your Multiple Myeloma Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe Multiple Myeloma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Multiple Myeloma Hub cannot guarantee the accuracy of translated content. The Multiple Myeloma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Multiple Myeloma Hub is an independent medical education platform, sponsored by Bristol Myers Squibb, GSK, Johnson & Johnson, Pfizer, Roche and Sanofi. The levels of sponsorship listed are reflective of the amount of funding given. Digital educational resources delivered on the Multiple Myeloma Hub are supported by an educational grant from Janssen Biotech, Inc. View funders.
DREAMM-9 updated interim analysis: Belantamab mafodotin in combination with SoC in transplant-ineligible NDMM
Bookmark this article
|
Belantamab mafodotin (belamaf) is a first-in-class BCMA-directed ADC currently under evaluation as a single agent and in combination with other treatments in R/R and NDMM in the DREAMM clinical trial program.1 DREAMM-9 (NCT04091126) is an ongoing randomized phase I dose optimization study investigating belamaf in combination with VRd in patients with TI NDMM (N = 108).1 The trial includes eight cohorts (C1–8) with differing belamaf doses, schedules, and follow-up: C1, 1.9 mg/kg Q3/4W (n = 12); C2, 1.9 mg/kg Q6/8W (n = 12); C3, 1.4 mg/kg Q3/4W (n = 13); C4, 1.4 mg/kg Q6/8W (n = 12); C5, 1.9 mg/kg for 1 dose and then 1.4 mg/kg Q9/12W (n = 19); C6, 1.0 mg/kg Q3/4W (n = 15); C7, 1.4 mg/kg for 1 dose and then 1.0 mg/kg Q9/12W (n = 15); C8, 1.0 mg/kg Q12W (n = 10).1 An updated interim analysis of data across all cohorts from the DREAMM-9 trial was presented by Usmani at the 66th ASH Annual Meeting and Exposition.1 |
| Key learnings |
| ORRs ranged from 71–100%, with a 100% ≥VGPR rate in three cohorts, including those with lower doses and less frequent dosing schedules. ≥CR rates in C1–4 ranged from 62–92%, and responses deepened over time. |
| Higher belamaf starting doses were associated with deeper and faster MRD- rates, regardless of dosing interval. In C1, 100% of patients with a CR achieved MRD negativity. |
| Rates of belamaf-related Grade 3/4 AEs were lowest among cohorts with lower doses and longer dosing intervals. Belamaf-related Grade 3/4 AEs occurred in 33% of 105 safety-evaluable patients. The most frequent non-ocular Grade 3/4 AEs were thrombocytopenia (30%), neutropenia (26%), and COVID-19 pneumonia (14%). |
| These findings show that belamaf + VRd produced highly effective tumor responses across all dosing schedules in patients with TI NDMM, with higher doses of belamaf associated with higher rates of MRD negativity. |
Abbreviations: ≥CR, complete response or better; ≥VGPR, very good partial response or better; ADC, antibody–drug conjugate; AE, adverse event; belamaf, belantamab mafodotin; BCMA, B-cell maturation antigen; C, cohort; CR, complete response; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; QxW, every x weeks; RR, relapsed/refractory; TI, transplant ineligible; VRd, bortezomib, lenalidomide, and dexamethasone.
- Usmani SZ. Phase I study of belantamab mafodotin in combination with standard of care in transplant-ineligible newly diagnosed multiple myeloma: Dreamm-9 updated interim analysis. Oral abstract #497. 66th American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 10, 2024; San Diego, US.
Your opinion matters
1 vote - 42 days left ...
Related articles
Newsletter
Subscribe to get the best content related to multiple myeloma delivered to your inbox