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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-8 study overview
DREAMM-8 was a Phase III, multicentre, open-label, randomised trial that evaluated BLENREP, pomalidomide and dexamethasone (BPd) as compared with pomalidomide, bortezomib and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma after at least one line of therapy, including a lenalidomide-containing regimen.2
The primary endpoint was PFS. Key secondary endpoints were OS, ORR, duration of response, and MRD-negative status.2
*Data cut-off January 2024; probability of PFS at 12 months for BPd was 71% (95% CI: 63–78); and for PVd 51% (95% CI: 42–60). HR for disease progression or death, 0.52; 95% CI: 0.37–0.73; P<0.001). †Efficacy data are based on the ITT population with a data cut-off of January 29, 2024. Response was based on IRC per IMWG criteria.
Primary endpoint
BLENREP + Pd delays disease progression or death vs PVd with median PFS not reached vs 12.7 months*1
A growing number of patients are becoming lenalidomide-exposed and refractory at first relapse due to extensive use of lenalidomide-based therapy in first line.4
In the DREAMM-8 clinical trial:
100% of patients were lenalidomide-exposed in both treatment arms.2
81% of patients were lenalidomide-refractory in the BLENREP + Pd arm compared with 76% of patients in the PVd arm.2
Treatment of this lenalidomide-exposed patient population with BLENREP + Pd resulted in a 48% reduction in risk of disease progression or death vs PVd.1,2
*Data cut-off January 2024; probability of PFS at 12 months for BPd was 71% (95% CI: 63–78); and for PVd 51% (95% CI: 42–60). Hazard ratio: 0.52 (95% CI: 0.37–0.73); †By Kaplan-Meier method. ‡By Brookmeyer and Crowley method. §Based on stratified Cox regression model. ¶One-sided p-value based on stratified log-rank test.
EHA update – Primary endpoint
BLENREP + Pd delays disease progression or death vs PVd with a median PFS of 32.6 months vs 12.5 months5
Median PFS reached significance at primary analysis (P<.00001); no further testing done.
Adapted from Dimopoulos MA, et al. EHA 2025.5
Secondary endpoint
A trend towards improved OS favoured BLENREP + Pd vs PVd, but median OS has not been reached yet*1,2
In the DREAMM-8 trial, median OS was not reached at the time of primary analysis. However, the number of events for BPd were lower than PVd (49 [32%] vs 56 [38%]) and the 12-month survival probability was 83% for BLENREP + Pd vs 76% for PVd.1
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*Efficacy data are based on the ITT population.1 †By Kaplan-Meier method. At the data cut-off, data on overall survival were 35% mature.2
Twice as many patients achieved a complete response rate or better with BLENREP + Pd (40%) vs PVd (17%)*3
Treatment with BLENREP + Pd resulted in 77% of patients responding to therapy (partial response or better) vs 72% with PVd. Of these patients, twice as many achieved a complete response rate or better with BLENREP + Pd vs PVd.*†3
Adapted from Dimopoulos MA, et al. NEJM 2024.3
*BPd: 40% n=62/155; PVd: 17%, n=25/147. †Response was based on IRC per IMWG criteria.1 ‡For patients with a partial response or better.1 §ORR: sCR+CR+VGPR+PR.1
BLENREP + Pd shows a trend towards a greater depth of response vs PVd3
MRD negativity is associated with significantly improved survival outcomes compared to MRD positivity.6 In the DREAMM-8 trial, 23.9% of patients receiving BLENREP + Pd vs 4.8% of patients receiving PVd achieved a complete response or better and MRD negativity.1,2
Adapted from Dimopoulos MA, et al. NEJM 2024.3
*Response was based on IRC per IMWG criteria.1 †For patients with a complete response or better.1 ‡Assessed by NGS at 10-5 threshold.1
BLENREP + Pd was observed to show a longer duration of response vs PVd3
In the DREAMM-8 trial, more patients receiving BLENREP + Pd achieved a 12-month duration of response than patients receiving PVd.3
Adapted from Dimopoulos MA, et al. NEJM 2024.3
The 12-month DoR rate was 79% (95% CI 71–86) for BPd compared with 61% (95% CI 50–70) for PVd. There were 39 (33%) events in the BPd arm compared with 49 (46%) events in the PVd arm.
*Patients with follow-up ended includes patients who have not experienced the event and have withdrawn from study (or started new anti-myeloma therapy) and therefore have missing outcome data. No further data collection is expected. †Patients with follow-up ongoing includes patients with ongoing response that are still on study and continue to be followed for the outcome.
Patients report comparable quality of life with BLENREP + Pd vs PVd1–3
The HRQoL of patients taking part in the DREAMM-8 study was assessed using the EORTC QLQ-C30 questionnaire.3 Patients in both treatment arms, BLENREP + Pd and PVd, reported a comparable quality of life while receiving treatment.3
Plot of change from baseline of EORTC QLQ-C30 Global Health Status/QoL Domain Score by visit*†3
Adapted from Dimopoulos MA, et al. NEJM 2024.3
*Confidence limits were only populated if n ≥3. †‘n’ for baseline is the number of participants with non-missing baseline score. ‘n’ for post-baseline visits is the number of participants with non-missing change from baseline, where both baseline and post-baseline score is non-missing.3
Safety profile summary of BLENREP (belantamab mafodotin) + Pd and PVd
The following table provides a summary of the safety profile seen with BLENREP + Pd and PVd in the DREAMM-8 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 (%) | BPd (N=150) | PVd (N=145) |
|---|---|---|
| Any AE | 149 (>99) | 139 (96) |
| Related to any study treatment* | 143 (95) | 118 (81) |
| Grade 3/4 AE† | 136 (91) | 106 (73) |
| Related to any study treatment* | 120 (80) | 85 (59) |
| AEs leading to permanent discontinuation of any study treatment | 22 (15) | 18 (12) |
| Related to any study treatment leading to permanent discontinuation of any study treatment* | 19 (13) | 9 (6) |
| AEs leading to dose reduction | 92 (61) | 88 (61) |
| AEs leading to dose delay | 136 (91) | 109 (75) |
| Any SAE | 95 (63) | 65 (45) |
| Related to any study treatment* | 45 (30) | 21 (14) |
| Fatal SAEs | 17 (11) | 16 (11) |
| Related to any study treatment* | 3 (2) | 0 |
Exposure-adjusted rates are provided to help establish the relative safety profiles of BLENREP + Pd vs PVd when levels of treatment exposure (per 100 person-years) are considered.3
| Exposure-adjusted rate (per 100 person-years)‡3 | BPd (N=150) | PVd (N=145) |
|---|---|---|
| Grade 3/4 AE | 66 | 78 |
| AEs leading to permanent discontinuation of any study treatment | 11 | 13 |
| AEs leading to dose reduction | 44 | 65 |
| AEs leading to dose delay | 66 | 80 |
| Any SAE | 46 | 48 |
Median duration of exposure to any trial drug was 16.54 months (range 0.92–35.06 months) for BLENREP + Pd and 8.51 months (range 0.26–39.85 months) for PVd.
BLENREP dosing can be delayed, reduced, or discontinued as part of a strategy to manage side effects.§1
For full information, please 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-8 study it was 15%.
With BLENREP + Pd, the most frequently reported non-eye-related side effects (≥20%) were neutropenia, thrombocytopenia, anaemia, upper respiratory tract infection, pneumonia, fatigue, and diarrhoea1–3
Side effects in DREAMM-8 were split into non-eye-related and eye-related.
DREAMM-8 side effect profile reported in ≥10% of patients in the BPd treatment arm (safety population)1
| BPd (N=150) | |||
|---|---|---|---|
| System organ class | Side effects* | All Grades (%) | Grade ≥3 (%) |
| Blood and Lymphatic System Disorders | Neutropenia† | 63 | 57 |
| Thrombocytopenia† | 55 | 38 | |
| Anaemia | 23 | 10 | |
| Infections and Infestations | Upper respiratory tract infection | 27 | 1 |
| Pneumonia | 24 | 16 | |
| General Disorders and Administration Site Conditions | Fatigue | 27 | 6 |
| Pyrexia | 19 | <1 | |
| Gastrointestinal Disorders | Diarrhoea | 23 | 1 |
| Nausea | 12 | <1 | |
| Investigations | Increased alanine aminotransferase | 15 | 1 |
| Increased aspartate aminotransferase | 10 | 3 | |
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 + Pd.1
IVIg was required by 18% of patients receiving BPd and 9% receiving PVd.3
*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 (ERSEs) with BLENREP + Pd are detected through ophthalmic examinations (which includes keratopathy)1
ERSEs observed with BLENREP + PVd in DREAMM-8 (n=150)1,2
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 | 91 | 60 |
| Corneal examination findings | 87 | 62 |
| Corneal ulcers (including cases with infection) | 2 | <1 |
| Vision blurred | 79 | 17 |
| Dry eye | 61 | 8 |
| Foreign body sensation in eyes | 61 | 6 |
| Eye irritation | 50 | 4 |
| Photophobia | 44 | 3 |
| Eye pain | 33 | 2 |
| Visual impairment | 15 | 10 |
| Lacrimation increased | 6 | <1 |
| Diplopia | 5 | <1 |
| Eye pruritus | 3 | <1 |
| 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 the posology section in the SPC for more information.
Find out how you can help your eligible 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 examples7
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.
Learn about BLENREP dosing and administration for each of the treatment combinations.
Abbreviations
AE, adverse event; BPd, belantamab mafodotin, pomalidomide and dexamethasone; CI, confidence interval; CR, complete response; CRS, cytokine release syndrome; DoR, duration of response; EORTC, European Organisation for Research and Treatment of Cancer; ERSE, eye-related side effects; 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; NGS, next-generation sequencing; NR, not reached; ORR, overall response rate; OS, overall survival; Pd, pomalidomide and dexamethasone; PFS, progression-free survival; PR, partial response; PVd, pomalidomide, bortezomib and dexamethasone; QLQ-C30, core quality of life questionnaire; QoL, quality of life; SAE, serious adverse event; sCR, stringent complete response; SPC, summary of product characteristics; VGPR, very good partial response.
References
- BLENREP Summary of Product Characteristics. GlaxoSmithKline. 2025.
- Dimopoulos MA, Beksac M, Pour L, et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med 2024;391(5):408–421.
- Dimopoulos MA, Beksac M, Pour L, et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med 2024;391(5):408–421, Supplemental Appendix.
- 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.
- Dimopoulos MA. Updated Results From Phase 3 DREAMM-8 Study of Belantamab Mafodotin Plus Pomalidomide and Dexamethasone vs Pomalidomide Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Poster presented at EHA (12th -16th June, Milan).
- 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.
- Gang Luo, PhD. Shi C, Pundlik S, Luo G. The Roles of Different Spatial Frequency Channels in Real-World Visual Motion Perception. bioRxiv. Available from https://www.biorxiv.org/content/10.1101/328443v1.full. Accessed October 2025.
▼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-250008 (V1.0)
