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DREAMM-2 safety summary
BLENREP safety
BLENREP has a generally manageable safety profile1
For GB healthcare professionals only.*
Table of contents
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
BLENREP is generally well-tolerated with a manageable safety profile. 12% (n=11) of patients discontinued treatment permanently due to adverse events.2
Eye-related side effects associated with BLENREP were manageable and generally resolved over time1,2
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
†Discontinuation included one patient with keratopathy, one patient with blurred vision, and one patient with reduced visual acuity.2
‡Recovery is defined as resolution or return to baseline. DREAMM-2 13-month follow up.
Incidence and resolution of eye-related side effects
| BLENREP, 2.5 mg/kg (n=95) |
|||
|---|---|---|---|
| Keratopathy |
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) |
Adapted from Nooka A et al. ASH 2022 DREAMM-2 final analysis
*Duration defined as time from onset of any keratopathy event to first time subject is free from event.
†Resolution defined as having a post-baseline score ≥20/50 or no equivalent value in either eye.
A gap of ≥1 day was required between resolution of first and occurrence of second event.
BLENREP AEs can be managed through dose delays and modifications, whilst continuing to provide sustained efficacy3
Learn more about how to manage side effects with dose modifications, so you can keep your patients on treatment.
Effect on disease symptoms and health-related QoL
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
BL, baseline; EORTC-QLQ-C30, European Organisation for Research and Treatment of cancer quality of life questionnaire; OSDI, Ocular Surface Disease Index; QoL, quality of life.
The European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC-QLQ-C30) is a 30 item, cancerspecific measure of global health-related quality of life. The Ocular Surface Disease Index (OSDI) is an ophthalmic vision–related PRO questionnaire used to characterise the impact of corneal events on patient symptoms and visual function. In DREAMM-2, patients completed PRO questionnaires electronically at baseline and Q3W during treatment.
See our resources for more support with BLENREP
Find out more about what BLENREP can offer your patients
*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
Abbreviations
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.
References
- BLENREP Summary of Product Characteristics.
- Nooka S, et al. Presented at the 64th American Society of Hematology Annual Meeting and Exposition, New Orleans, USA, December 10-13, 2022. Poster 3246.
- Lonial S, et al. Cancer. 2021;127(22):4198–4212.
- Popat R, et al. Presented at the 62nd American Society of Hematology Annual Meeting. 2020. #2278.
▼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)
