DREAMM-2 safety summary
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BLENREP has a generally manageable safety profile1
For GB healthcare professionals only.*
In the 13-month follow-up 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. Responses to BLENREP were fast, deep and durable.2
BLENREP is generally well-tolerated with a manageable safety profile:1
In the DREAMM-2 clinical trial:1,2
of affected patients (n=46/60) had recovered from their first keratopathy event by data cut-off, highlighting their reversibility2‡
of responses (n=14/16) were sustained or deepened, despite prolonged dose delays2
Median time to onset of Grade ≥2 corneal findings1
Median time to resolution of Grade ≥2 corneal findings1
of patients (n=3/95) discontinued treatment due to eye-related side effects†2
*Clinically meaningful BCVA change represents a BCVA of Snellen Visual Acuity 20/50 or worse in the better-seeing eye.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.
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 13 month follow up (cut-off date 31 Jan 2020). 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.
*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
▼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.
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November 2022 | PM-GB-BLM-WCNT-220004 (V1.0)