DREAMM-2 safety summary
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BLENREP has a generally manageable safety profile1
For GB healthcare professionals only.*
In the final analysis of the DREAMM-2 trial, BLENREP (administered as 2.5 mg/kg every 3 weeks) delivered an overall response rate of 32% (n=31/97; 95% CI 21.7-43.6) in triple-refractory patients with multiple myeloma. 58% (n=18) of responding patients achieved a ≥VGPR. Responses to BLENREP were fast, deep and durable.2
Outcome, n (%)
2.5 mg/kg cohort (N=95)
Any-grade AEs, n (%)
Grade ≥3 AEs, n (%)
Most frequent AEs, (any grade), n (%)
|Grade 3||28 (29)|
|Grade 4||1 (1)|
|Grade 4||12 (13)|
|Grade 3||20 (21)|
|Grade 4||0 (0)|
|Blurred vision*†||24 (25)|
|BCVA reduced to 20/50 or worse||46 (48)|
Overall infection rate, n(%)
Grade ≥3 infections
Most frequent infections (any grade), n(%)
|Upper respiratory tract infection||10 (11)|
Fatal SAEs, n(%)
Treatment related fatal SAEs, n(%)
Table adapted from Nooka et al. 20222
In the DREAMM-2 clinical trial:2
of affected patients (n=49/67) had recovered from their first keratopathy event by the final analysis data cut off, highlighting their reversibility2‡
of responses (n=14/16) were sustained or deepened, despite prolonged dose delays (from post-hoc analysis in 13 month follow up).3
Median time to resolution of first event of BCVA reduction to 20/50 or worse at final analysis (range 50-103 days)2
of patients (n=5/95) discontinued treatment due to eye-related side effects†2
|BLENREP, 2.5 mg/kg (n=95)
||Blurred vision||BCVA reduced to 20/50 or worse|
|Incidence, % (n)||71% (67)||25% (24)||48% (46)|
|Median time to resolution of first event, days (range)||120.0* (8–858)||43.0 (6–895)||23.0 † (5–103)|
|Recovered as of last assessment, % (n)||73% (49/67)||79% (19/24)||87% (40/46)|
Learn more about how to manage side effects with dose modifications, so you can keep your patients on treatment.
With BLENREP, there was no change in overall patient-reported Global Health Status/QoL, Physical Functioning, or Role Functioning domain scores of the EORTC-QLQ-C30 at the final readout. This included patients with a minimal meaningful withinpatient reduction in vision-related function by Ocular Surface Disease Index (OSDI).3
*BLENREP is not commercially available in Northern Ireland.
BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.1
AE, adverse event; AESI, adverse event of special interest; BCVA, best corrected visual acuity; BL, baseline; CI, confidence interval; CTCAE, Common Terminology Criteria for Adverse Events; CTD, cyclophosphamide, thalidomide and dexamethasone; DREAMM-2, DRiving Excellence in Approaches to Multiple Myeloma 2; ECOG PS, Eastern Cooperative Oncology Group Performance Status; eGFR, estimated glomerular filtration rate; EORTC-QLQ-C30, European Organisation for Research and Treatment of cancer quality of life questionnaire; FISH, fluorescent in-situ hybridisation; Hb, haemoglobin; Ixa Len Dex, ixazomib, lenalidomide and dexamethasone; Isa Pom Dex, isatuximab, pomalidomide and dexamethasone; MEC, microcyst-like epithelial change; MedDRA, Medical Dictionary for Regulatory Activities; OSDI, Ocular Surface Disease Index; PS, performance status; Q3W, every 3 weeks; QoL, quality of life; R-ISS, Revised International Staging System; SmPC, Summary of Product Characteristics; VCD, bortezomib, cyclophosphamide and dexamethasone.
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.
© 2022 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.
March 2023 | PM-GB-BLM-WCNT-220004 (V2.0)