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BLENREP safety

BLENREP has a generally manageable safety profile1

For GB healthcare professionals only.*

Table of contents

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

VIEW CLINICAL TRIAL AND EFFICACY DATA

DREAMM-2 safety summary (n=95)

*Clinically meaningful best corrected visual acuity (BCVA) change represents a BCVA of Snellen Visual Acuity 20/50 or worse in the better-seeing eye.2

BLENREP is generally well-tolerated with a manageable safety profile:1

  • 9% (n=9) of patients permanently discontinued treatment because of AEs
  • There were no reports of cytokine release syndrome and 7% (n=7) of patients experienced Grade ≥3 infections with BLENREP
  • System organ class Adverse reactions* BLENREP 2.5 mg/kg (N=95)
    Any Grade (%) Grade 3/4 (%)
    Eye disorders Keratopathy 71 31
    Blurred vision events 25 4
    Dry eye events§ 15 1
    Photophobia 4 0
    Eye irritation 3 0
    Ulcerative keratitis 1 1
    Infective keratitis 1 1
    Infections and infestations Pneumonia 11 7
    Upper respiratory tract infection 9 0
    Blood and lymphatic system disorders Thrombocytopenia# 38 22
    Anaemia 27 21
    Lymphopenia** 20 17
    Leukopenia✝✝ 17 6
    Neutropenia‡‡ 15 11
    Gastrointestinal disorders Nausea 25 0
    Diarrhoea 13 1
    Vomiting 7 2
    General disorders and administration site conditions Pyrexia 23 4
    Fatigue 16 2
    Investigations Increased aspartate aminotransferase 21 2
    Increased gamma glutamytransferase 11 3
    Increased creatine phosphokinase 5 2
    Injury, poisoning and procedural complications Infusion-related reactions§§ 21 3
    Renal and urinary disorders Albuminuria¶¶ 2 1

    Table adapted from the SmPC1

    *Adverse reactions coded using MedDRA (Medical Dictionary for Regulatory Activities) and graded for severity based on Common Terminology Criteria for Adverse Events (CTCAE v4.03).1
    Based on eye examination, characterised as corneal epithelium changes with or without symptoms.1
    Includes diplopia, vision blurred, visual acuity reduced, and visual impairment.1
    §Includes dry eye, ocular discomfort, and eye pruritus.1
    Includes pneumonia and herpes simplex pneumonia.1
    #Includes thrombocytopenia and decreased platelet count.1
    **Includes lymphopenia and decreased lymphocyte count.1
    ✝✝Includes leukopenia and decreased leukocyte count.1
    ‡‡ncludes neutropenia and decreased neutrophil count.1
    §§Includes events determined by investigators to be related to infusion. Infusion reactions may include, but are not limited to, pyrexia, chills, diarrhoea, nausea, asthenia, hypertension, lethargy, and tachycardia.1
    ¶¶Identified from patients across the BLENREP clinical program including study 205678. The frequency is based on the program-wide exposure.1

  •   BLENREP, 2.5 mg/kg (n=95) Price
    AESIs Any Grade, n (%) Grade ≥3, n (%)
    Thrombocytopenia* 36 (38) 21 (22)
    Infusion-related reactions 20 (21) 3 (3)
    Keratopathy (MECs) 68 (72) 44 (46)

    13-month follow-up

    Adapted from Lonial S et al. Cancer. 2021.
    AESI, adverse event of special interest; MEC, microcyst-like epithelial change.

    *Thrombocytopenia (considered an AESI) includes preferred terms thrombocytopenia and platelet count decreased.2
    Infusion-related reactions (considered an AESI) includes preferred terms infusion-related reaction, pyrexia, chills, diarrhoea, nausea, asthenia, hypertension, lethargy, and tachycardia occurring within 24 hours of infusion.2

    Changes in the corneal epithelium observed on eye examination. Graded per protocol defined scale which was renamed as the Keratopathy and Visual Acuity scale.2

Eye-related side effects associated with BLENREP generally resolved over time1,2

In the DREAMM-2 clinical trial:1,2

Patient with 77% icon

of affected patients (n=46/60) had recovered from their first keratopathy event by data cut-off, highlighting their reversibility2‡

Patient with 88% icon

of responses (n=14/16) were sustained or deepened, despite prolonged dose delays2

Eye with 18% (n=78/95) icon

experienced a clinically significant visual acuity change* 2

Calendar with 36 days icon

Median time to onset of Grade ≥2 corneal findings1

Calendar with 91 days icon

Median time to resolution of Grade ≥2 corneal findings1

Stop hand with 3% icon

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.

BLENREP AEs can be managed through dose delays and modifications, whilst continuing to provide sustained efficacy2

Learn more about how to manage side effects with dose modifications, so you can keep your patients on treatment.

LEARN MORE ABOUT DOSE MODIFICATIONS

Collaborate with eye care professionals* to effectively monitor for eye-related side effects1

Utilise the ‘3 Ms management plan’ for eye-related side effects:1

Infographic outlining the 3 Ms of eye-related side effect management – monitor, minimise and modify

*An eye care professional can be an ophthalmologist or optometrist.
Refer to the SmPC for more information.

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 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

Global Health Status/QoL

Graph showing overall patient-reported Global Health Status/QoL in DREAMM-2

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

VIEW RESOURCES

Real-world patient case studies

Watch the experts present patient case studies to support management eye-related side effects associated with BLENREP

*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

  1. BLENREP Summary of Product Characteristics.
  2. Lonial S, et al. Cancer. 2021;127(22):4198–4212.
  3. 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.

November 2022 | PM-GB-BLM-WCNT-220004 (V1.0)