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BLENREP is indicated in adults for the treatment of multiple myeloma:1
- In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
- In combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide
DREAMM-7 study overview
DREAMM-7 was a phase III, open-label, randomised trial that evaluated BLENREP, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary endpoint was PFS. Key secondary endpoints were OS, response duration, and MRD–negative status.2
*Median progression-free survival was 36.6 months (95% CI: 28.4–NR) in the BVd group and 13.4 months (95% CI: 11.1–17.5) in the DVd group. HR for disease progression or death, 0.41; 95% CI: 0.31–0.53; P<0.00001). †36-month survival in BVd was 74% (95% CI: 68–79) vs 60% (95% CI: 54–66) in DVd (HR 0.58; 95% CI: 0.43–0.79; p=0.00023). Median OS in either arm was not reached. At 171 actual events (48.2% OS information), OS was declared significant if the P value was <0.00112.
Primary endpoint
BLENREP (belantamab mafodotin) + Vd demonstrates superiority vs DVd with a median PFS of 36.6 months vs 13.4 months*†1,4
59% reduction in risk of progression or death with BLENREP + Vd vs DVd.1 (HR=0.41; 95% CI: 0.31–0.53 [P=0.00001])
*Efficacy data are based on the ITT population with a data cutoff of October 2, 2023.1 †Response was based on IRC per IMWG criteria.1 ‡By Brookmeyer and Crowley method.1 §Based on stratified Cox regression model.1 ¶One-sided P value based on stratified log-rank test.
Post hoc analysis
Progression-free survival in lenalidomide-refractory patients
A growing number of patients with multiple myeloma are lenalidomide-exposed and/or refractory at first relapse.5
Lenalidomide exposure has been shown to impact subsequent multiple myeloma PFS; subgroup analyses of existing lenalidomide-sparing regimens showed the median PFS of lenalidomide-refractory patients is around 10 months, demonstrating the need for additional treatment options for these patients.6,7,8,9
In a post hoc analysis from the DREAMM-7 study, patients who received BLENREP + Vd showed a numerically longer PFS of 25.0 months vs 8.6 months with DVd.10
This has not been tested for significance.
Adapted from Mateos et al. EHA 202411
*HRs were estimated using Brookmeyer and Crowley method. 95% CI were not adjusted for multiplicity and cannot be used for hypothesis testing.
Secondary endpoint
BLENREP (belantamab mafodotin) + Vd is the first second-line triplet to show a significant OS benefit vs another triplet in Phase III clinical trials*2,9,11-14
In the DREAMM-7 BLENREP trial, overall survival was a key secondary endpoint.3 BLENREP + Vd was shown to significantly improve overall survival vs DVd based on the second interim analysis.*1,2
*36-month survival in BVd was 74% (95% CI: 68–79) vs 60% (95% CI: 54–66) in DVd (HR 0.58; 95% CI: 0.43–0.79; p=0.00023). Median OS in either arm was not reached. At 171 actual events (48.2% OS information), OS was declared significant if the P value was <0.00112. Median follow-up of 39.4 months.
Twice as many patients achieved a complete response rate or better with BLENREP + Vd (35.8%) vs DVd (17.5%)*†2
Treatment with BLENREP + Vd resulted in 83.1% of patients responding to therapy (partial response or better) vs 71.3% with DVd. Of these patients, twice as many achieved a complete response rate or better with BLENREP + Vd vs DVd.*†‡§2
Adapted from Hungria et al, ASH 2024.2
*BVd 35.8%, n=87/243; 95% CI: 29.8–42.2%; DVd 17.5%, n=44/251; 95% CI 13.0–22.8%. †Data cut-off October 2024; median follow-up of 39.4 months. ‡CIs were based on the exact method. Two patients in the ITT population were randomised, not treated, rescreened, and re-randomised. They are counted as 4 unique patients in this output. §Median follow-up was 39.4 months (range: 0.1–52.3 months).
MRD negativity rates are significantly greater with BLENREP + Vd vs DVd*†‡2
MRD negativity is associated with significantly improved survival outcomes compared to MRD positivity.15 In the DREAMM-7 trial, 25.1% of patients receiving BLENREP + Vd vs 10.4% of patients receiving DVd achieved a complete response or better and MRD negativity.§2
Adapted from Hungria et al, ASH 2024.2
*Since OS is significant in the DREAMM-7 analysis, the MRD-negativity results from the primary analysis can now be considered statistically significant due to testing hierarchy. †DREAMM-7 testing hierarchy was PFS, followed by OS, followed by MRD. ‡CIs were based on the exact method. Two patients in the ITT population were randomised, not treated, rescreened, and re-randomised. They are counted as 4 unique patients in this output. MRD-negativity rate is defined as the percentage of patients who were MRD negative by NGS based on a sensitivity of 10−5. §Median follow-up was 39.4 months (range: 0.1–52.3 months).
Patients receiving BLENREP + Vd were observed to achieve more than double the median duration of response vs DVd.*†2
BLENREP + Vd offered patients a longer duration of response vs DVd in the DREAMM-7 trial.2 The median duration of response of patients receiving BLENREP + Vd was 23 months longer than those receiving DVd.‡2
Adapted from Hungria et al, ASH 2024.2
*Two patients in the ITT population were randomised, not treated, re-screened, and re-randomised. They are counted as 4 unique patients in this output. †CIs estimated using the Brookmeyer-Crowley method. ‡Median follow-up was 39.4 months (range: 0.1-52.3 months).
Patients with multiple myeloma report comparable quality of life with BLENREP (belantamab mafodotin) + Vd vs DVd*†3
Quality of life in patients with multiple myeloma can often be impacted by treatment.16 In the DREAMM-7 trial, patients being treated with BLENREP + Vd reported a comparable quality of life to those treated with DVd.3
Plot of change from baseline of EORTC QLQ-C30 Global Health Status/QoL Domain Score by visit*3
Adapted from Hungria et al, NEJM 2024.3
*Two patients in the ITT population were randomised, not treated, re-screened, and re-randomised. They are counted as 4 unique patients in this output.3 †HRQoL was not assessed in patients post-progression. Disease progression could impact HRQoL, which is not captured in this figure. More patients in the DVd group experienced disease progression compared with the BVd group.3
Safety profile summary of BLENREP (belantamab mafodotin) + Vd and DVd
The following table provides a summary of the safety profile seen with BLENREP + Vd and DVd in the DREAMM-7 trial, including where side effects resulted in dosing modifications of delays, reductions, or discontinuations.1–3
For more information on special warnings and SPC recommended dose modifications, see managing side effects.
| n (%) | BVd (N=242) | DVd (N=246) |
|---|---|---|
| Any AE | 242 (100) | 246 (100) |
| Related to any study treatment* | 242 (100) | 234 (95) |
| Grade 3/4 AE† | 230 (95) | 191 (78) |
| Related to any study treatment* | 222 (92) | 166 (67) |
| AEs leading to permanent discontinuation of any study treatment | 77 (31) | 47 (19) |
| Related to any study treatment leading to permanent discontinuation of any study treatment* | 67 (28) | 36 (15) |
| AEs leading to dose reduction | 181 (75) | 146 (59) |
| AEs leading to dose delay | 229 (95) | 186 (76) |
| Any SAE | 129 (53) | 94 (38) |
| Related to any study treatment* | 50 (21) | 32 (13) |
| Fatal SAEs | 26 (11) | 20 (8) |
| Related to any study treatment* | 7 (3) | 2 (<1) |
Exposure-adjusted rates are provided to help establish the relative safety profiles of BLENREP + Vd vs DVd when levels of treatment exposure (per 100 person-years) are considered.3
| Exposure-adjusted rate (per 100 person–years)‡3 | BVd (N=242) | DVd (N=246) |
|---|---|---|
| Grade 3/4 AE | 57.17 | 55.71 |
| AEs leading to permanent discontinuation of any study treatment | 19.14 | 13.71 |
| AEs leading to dose reduction | 44.99 | 42.58 |
| AEs leading to dose delay | 56.92 | 54.25 |
| Any SAE | 32.07 | 27.42 |
The median duration of exposure to any trial drug was 15.9 months (range: 0.69–40.2) for BLENREP + Vd and 12.9 months (range: 0.23– 40.5) for DVd.1
BLENREP dosing can be delayed, reduced, or discontinued as part of a strategy to manage side effects.§1 Explore the SPC special warnings and recommended approach to managing side effects.
*“Related to any study treatment” includes responses of “yes” and missing responses to the following question: “Is there a reasonable possibility that the AE may have been caused by the study treatment?”. †Includes any patient with a grade 3 or 4 AE. ‡Exposure-adjusted rates were calculated as the total number of patients with an event divided by the total exposure time in person years (per 100 person-years). Total person-years is the sum of all patient exposure calculated as (last dose - first dose + 1)/365.25. §Discontinuation rate of any component of therapy in the DREAMM-7 study was 31%, and in the DREAMM-8 study it was 15%.
With BLENREP (belantamab mafodotin) + Vd, the most frequently reported non-eye-related side effects (≥20%) were thrombocytopenia, diarrhoea, and upper respiratory tract infection*1,2,4
DREAMM-7 side effect profile reported in ≥15% of patients in the BVd treatment arm (safety population)1
| BVd (N=242) | |||
|---|---|---|---|
| System organ class | Side effect | All Grades (%) | Grade ≥3 (%) |
| Blood and Lymphatic System Disorders | Thrombocytopenia† | 87 | 73 |
| Anaemia | 19 | 8 | |
| Neutropenia† | 17 | 14 | |
| Gastrointestinal Disorders | Diarrhea | 32 | 4 |
| Nausea | 16 | <1 | |
| Infections and Infestations | Upper respiratory tract infection | 20 | 0 |
| Pneumonia | 18 | 9 | |
| General Disorders and Administration Site Conditions | Pyrexia | 19 | <1 |
| Fatigue | 19 | 4 | |
| Investigations | Increased alanine aminotransferase | 19 | 6 |
| Increased aspartate aminotransferase | 15 | 1 | |
| Increased gamma glutamyltransferase | 15 | 9 | |
Please refer to the SPC or managing side effects page for a full list of side effects and special warnings.
No report of CRS or ICANS with the use of BLENREP + Vd.1
IVIg was required by 8% of patients receiving BVd and 4% receiving DVd.1
*AEs were graded with use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. †Grouped term includes other related terms.
The two most frequently reported eye-related side effects with BLENREP (belantamab mafodotin) + Vd are detected through ophthalmic examinations1
ERSEs observed with BLENREP + Vd in DREAMM-7 (n=242)1,4
Patients should have an ophthalmic examination performed by an eye care professional before each of the first 4 doses of BLENREP, and as clinically indicated thereafter.1 See supporting patients for more information.
| Eye-related side effects | All Grades (%) | Grade ≥3 (%) |
|---|---|---|
| Visual acuity reduced | 89 | 57 |
| Corneal examination findings | 86 | 72 |
| Corneal ulcers (including cases with infection) | <1 | <1 |
| Vision blurred | 66 | 22 |
| Dry eye | 51 | 7 |
| Photophobia | 47 | 2 |
| Foreign body sensation in eyes | 44 | 3 |
| Eye irritation | 43 | 5 |
| Eye pain | 32 | <1 |
| Visual impairment | 11 | 5 |
| Lacrimation increased | 9 | <1 |
| Diplopia | 5 | 0 |
| Eye pruritus | 2 | 0 |
| Ocular discomfort | 1 | 0 |
Cases of corneal ulcer have been reported. These should be managed promptly and as clinically indicated by an eye care professional. Treatment with BLENREP should be interrupted until the corneal ulcer has healed. Please see posology section in the SPC for more information.
Find out how you can help your patients understand and manage any ERSEs they might experience with eye care support.
For a full list of reported side effects, please refer to the SPC.
Visual acuity image examples
Examples of changes in visual acuity.
These images are only a theoretical depiction of visual ability and are for illustrative purposes only. They do not represent individual patient vision.
BLENREP offers two different treatment combinations to meet the needs of your eligible patients with multiple myeloma.1 Explore the DREAMM-8 BLENREP + Pd trial.
Learn about BLENREP dosing and administration for each of the treatment combinations
Abbreviations
AE, adverse event; BVd, belantamab mafodotin, bortezomib and dexamethasone; CI, confidence interval; CR, complete response; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; DVd, daratumumab, bortezomib and dexamethasone; EORTC, European Organisation for Research and Treatment of Cancer; ERSE, eye-related side effect; HR, hazard ratio; HRQoL, health-related quality of life; ICANS, immune effector cell associated neurotoxicity syndrome; IMWG, International Myeloma Working Group; IRC, independent review committee; ITT, intention-to-treat; IVIg, intravenous immunoglobulin; MRD, minimal residual disease; NR, not reached; ORR, overall response rate; OS, overall survival; Pd, pomalidomide and dexamethasone; PFS, progression-free survival; PR, partial response; QLQ-C30, core quality of life questionnaire; QoL, quality of life; SAE, serious adverse event; sCR, stringent complete response; SPC, summary of product characteristics; Vd, bortezomib and dexamethasone; VGPR, very good partial response.
References
- BLENREP Summary of Product Characteristics. GlaxoSmithKline; 2025.
- Hungria V, Robak P, Hus M, et al. Belantamab mafodotin, bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: Overall survival analysis and updated efficacy outcomes of the Phase 3 DREAMM-7 Trial. Presented at: 66th American Society of Hematology (ASH) Annual Meeting & Exposition; December 7–10, 2024; San Diego, CA, and virtual.
- Hungria V, et al. N Engl J Med 2024;391(5):393–407, Supplemental Appendix.
- Hungria V, Robak P, Hus M, et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(5):393–407.
- Moore S, Cornic L, Crossman-Barnes CJ, et al. Real-world characteristics and outcomes of patients with multiple myeloma receiving second-line treatment in England. eJHaem 2024;1–12.
- Mateos MV, Sonnevold P, Hungria V, et al. Daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone in patients with previously treated multiple myeloma: Three-year follow-up of CASTOR. Clinical Lymphoma, Myeloma & Leukemia 2020;20:509–518.
- Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol 2016;17:27–38.
- Moreau P, Joshua D, Chng W-J, et al. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia 2017;31:115–122.
- Mateos MV, Engelhardt M, Leleu X, et al. Efficacy, survival and safety of selinexor, bortezomib and dexamethasone (SVd) in patients with lenalidomide-refractory multiple myeloma: Subgroup data from the BOSTON trial. Presented at EHA Hybrid Congress 2023. June 8–11, 2023. Poster #P886.
- Mateos MV, Robak P, Hus M, et al. DREAMM-7 update: subgroup analyses from a phase 3 trial of belantamab mafodotin + bortezomib and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma. Presented at: EHA 2024. Poster #P938.
- Stewart KA, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, Lenalidomide and Dexamethasone for relapsed multiple myeloma. N Engl J Med 2015;372:142–152.
- Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib and dexamethasone for multiple myeloma. N Engl J Med 2016;375:754–766.
- Dimopoulos M, Weisel K, Moreau P, et al. Pomalidomide, bortezomib, and dexametasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse. Leukemia 2021;35:1722–1731.
- Dimopulos MA, Oriol A, Nahi H, et al. Overall survival with daratumumab, lenalidomide, and dexamethasone in previously treated multiple myeloma (POLLUX): A randomized, open-label, phase III trial. J Clin Oncol 2023;41(8):1590–1599.
- Munshi NC, Avet-Loiseau H, Anderson KC, et al. A large meta-analysis establishes the role of MRD negativity in long-term survival outcomes in patients with multiple myeloma. Blood Adv 2020;4(23):5988–5999.
- O’Donnell EK, Shapiro YN, Yee AJ, et al. Quality of life, psychological distress, and prognostic perceptions in patients with multiple myeloma. Cancer 2022;128(10):1996–2004.
▼This product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (available on the Apple App Store or Google Play Store). Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or UKSafety@GSK.com.
October 2025 | PM-GB-BLM-WCNT-250007 (V1.0)
