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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
Explore the DREAMM-8 study design

DREAMM-8 patient demographics and study design

DREAMM-8: BPd vs PVd eligibility criteria and patient characteristics

DREAMM-8 efficacy data showed that the BLENREP triplet (BPd) demonstrated superiority compared to a pomalidomide triplet (PVd), achieving an estimated 12-month progression-free survival (PFS) of 71% (95% confidence interval [CI]: 63–78) vs 51% (95% CI: 42–60), respectively (hazard ratio [HR]: 0.52; 95% CI: 0.37–0.73; P<0.001).1,2 Evidence showed a 48% reduction in the risk of disease progression or death with BPd vs PVd.1,2

The most frequent side effects (≥20%) in BPd included reduced visual acuity (91%), corneal examination findings (87%), blurred vision (79%), neutropenia (63%), foreign body sensation in eyes (61%), dry eye (61%), thrombocytopenia (55%), eye irritation (50%), photophobia (44%), eye pain (33%), fatigue (27%), upper respiratory tract infection (27%), pneumonia (24%), anaemia (23%), and diarrhoea (23%).1

Serious side effects of BPd occurred in 63% of patients. Serious side effects in ≥2% of patients included pneumonia (18%) and neutropenia (6%). Fatal adverse reactions occurred in 11% of patients and the most common was pneumonia (1%).1

BLENREP dosing can be delayed, reduced or discontinued as part of a strategy to manage side effects.*1–3

*Discontinuation rate of any component of therapy in the DREAMM-8 study was 15%.1

Discover more about the efficacy and safety profile in DREAMM-8

Discover more information on dosing, administration and special warnings with BLENREP

DREAMM-8 patient demographics and study design

In DREAMM-8, a total of 302 patients were evaluated for efficacy, and were randomly assigned to receive BPd (155 patients), or PVd (147 patients), and treatment was continued until the occurrence of progressive disease, unacceptable toxic effects, withdrawal of consent, or death. There was a median follow-up of 21.8 months.2

The primary endpoint was PFS as defined by the International Myeloma Working Group (IMWG). Key secondary endpoints included overall survival (OS), minimal residual disease (MRD)-negative status, and duration of response (DoR).2

DREAMM-8 study design*1,4

Image showing DREAMM-8 study design

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*Data cutoff = January 29, 2024; median follow-up was 21.8 months (<0.1-39.2).2

DREAMM-8: BPd vs PVd eligibility criteria and patient characteristics

Among those in the BPd treatment group, clinically relevant characteristics included:2

  • 23% of patients had prior daratumumab exposure
  • 34% had high-risk cytogenetics

Among those in the BPd treatment group in DREAMM-8, clinically relevant characteristics included:2

Image of a capsule

81% refractory to lenalidomide

Image of a syringe

23% exposed to daratumumab

Image of an IV drip

86% exposed to bortezomib

Clinically relevant characteristics in the PVd arm included:

  • 76% of patients refractory to lenalidomide
  • 27% of patients exposed to daratumumab
  • 88% of patients exposed to bortezomib

  • Eligibility criteria3

    Participants in DREAMM-8 were subject to the following eligibility criteria:3

    Key inclusion criteria:3 Key exclusion criteria:3
    • Adults with MM
    • ≥1 prior line of MM therapy that included lenalidomide
    • Progressive disease during or after most recent therapy
    • Prior treatment with anti-BCMA
    • Refractory treatment or intolerance of pomalidomide
    • Refractory to or intolerant of bortezomib
    • Current corneal epithelial disease*
    • Ongoing Grade ≥2 peripheral neuropathy with pain or Grade ≥3 peripheral neuropathy

    *Only patients with current corneal epithelial disease were excluded. Patients with prior or pre-existing eye-related issues, including mild punctate keratopathy, were not excluded.3

    In DREAMM-8, 100% of patients were LEN-exposed and 81% were LEN-refractory in the BPd arm2

    Stratification:3

    • Prior lines of treatment (1 vs 2 or 3 vs ≥4)
    • R-ISS stage (I vs II/III)
    • Prior bortezomib treatment (yes or no)
    • Prior anti-CD38 treatment (yes or no)†

    Enrollment of patients who had received more than one previous line of therapy was capped at 50%.

    †Some patients were stratified by ISS status (I vs II/III); the protocol was amended on April 20, 2021 to replace this randomisation factor with prior anti-CD38 treatment (yes vs no).2,3

  • The trial population in DREAMM-8 was closely representative of patients with multiple myeloma with respect to the sex distribution and the median age. However, Black patients were not represented, which is not reflective of the epidemiologic profile for MM.2

    Table of key patient characteristics in DREAMM-81,2

    BPd (N=155) Characteristics PVd (N=147)
    67 (40-82)
    Median age (yr), (range)
    		68 (34-86)
    Age category, n (%)
    64 (41%) 18 to <65 yr 53 (36%)
    91 (58%) ≥65 yr 94 (64%)
    Race*, n (%)
    133/155 (86%) White 127/146 (87%)
    0/155 Black 0/146
    20/155 (13%) Asian 17/146 (12%)
    1/155 (1%) Native Hawaiian or other Pacific Islander 2/146 (1%)
    1/155 (1%) Mixed race 0/146
    ISS disease stage at screening, n (%)
    93 (60%) Stage I 85 (58%)
    39 (25%) Stage II 40 (27%)
    22 (14%) Stage III 22 (15%)
    1 (1%) Unknown 0
    Extramedullary disease, n (%)
    20 (13%) Yes 11 (7%)
    135 (87%) No 136 (93%)
    ECOG performance status ≤1†, n/N (%)
    79/150 (53%) 0 84/145 (58%)
    67/150 (45%) 1 56/145 (39%)
    4/150 (3%) 2 5/145 (3%)
    52 (34%) Patients with high-risk cytogenetics‡, n (%) 47 (32%)
    99 (64%) Prior stem cell transplant, n (%) 82 (56%)

    *Race and ethnic group were reported by the patients. †Performance status score was evaluated in the safety population. BPd N=150 and PVd N=145. ‡High-risk cytogenetic factors [positive for t(4;14), t(14;16), or 17p13del].

  • The trial population in DREAMM-8 was closely representative of patients with multiple myeloma with respect to the sex distribution and the median age. However, Black patients were not represented, which is not reflective of the epidemiologic profile for MM.2

    Table of prior treatment exposure in DREAMM-81,2

    BPd (N=155) Previous lines of therapy, % (n) PVd (N=147)
    53% (82)
    1
    		52% (77)
    35% (54) 2 or 3 33% (48)
    12% (19) ≥4 15% (22)
    90% (140) Prior proteasome inhibitor, % (n) 93% (136)
    86% (134) Prior bortezomib, % (n) 88% (130)
    100% (155) Prior lenalidomide, % (n) 100% (147)
    81% (125) Refractory to lenalidomide, % (n) 76% (111)
    23% (36) Prior daratumumab, % (n) 27% (39)
    1% (2) Prior isatuximab, % (n) 2% (3)

Explore the efficacy and safety profile of BPd in DREAMM-8

Abbreviations

AE, adverse event; BCMA, B-cell maturation antigen; BPd, belantamab mafodotin, pomalidomide and dexamethasone; CD38, cluster of differentiation 38; CI, confidence interval; CRR, complete response rate; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; HRQoL, health-related quality of life; IMWG, International Myeloma Working Group; IRC, Independent Review Committee; ISS, international staging system; IV, intravenous; LEN, lenalidomide; MM, multiple myeloma; MRD, minimal residual disease; NR, not reached; ORR, overall response rate; OS, overall survival; Pd, Pomalidomide, and dexamethasone; PD, progressive disease; PFS, progression-free survival; PRO, patient-reported outcomes; PVd, pomalidomide, bortezomib and dexamethasone; Q4W, once every 4 weeks; R-ISS, revised international staging system; RRMM, relapsed/refractory multiple myeloma; SC, subcutaneous; TTBR, time to best response; TTP, time to progression; TTR, time to response; VGPR, very good partial response.

References

  1. BLENREP. Summary of Product Characteristics. GlaxoSmithKline; 2025.
  2. Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med. 2024 Aug 1;391(5):408–21.
  3. 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.
  4. Trudel S, Beksac M, Pour L, et al. Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone vs pomalidomide plus bortezomib and dexamethasone in relapsed/refractory multiple myeloma. Presented at: 2024 ASCO Annual Meeting; May 31-June 4, 2024; Chicago, IL.

▼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-250004 (V1.0)