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An Overview of BLENREP and Corneal Adverse Reactions for Eye

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An Overview of BLENREP and Corneal Adverse Reactions for Eye An Overview of BLENREP and Corneal Adverse Reactions for Eye Care Professionals Patients with relapsed or refractory multiple myeloma Table of Contents prescribed BLENREP (belantamab mafodotin) require an eye exam at baseline, before the subsequent 3 treatment cycles, and as clinically indicated whilst on treatment.1 Understanding a Patient With Relapsed/Refractory Multiple Myeloma .........4 Adverse reactions (ARs) have been reported with BLENREP, including corneal events, Overview of BLENREP ....................................................6 during clinical trials. Patients may be referred Efficacy of BLENREP in Patients With Relapsed/Refractory Multiple Myeloma ..8 to you by a haematologist/oncologist or Corneal ARs Observed in the DREAMM-2 (Study 205678) Clinical Trial .......10 may see you directly for their eye exams. MONITOR, MINIMISE, MODIFY: The 3 Ms of Corneal AR Management ........12 This guide is intended to provide you Dose Modifications for Corneal ARs ......................................18 an overview of why eye exams are required and what corneal ARs could Frequently Asked Questions .............................................20 potentially occur with BLENREP. References ............................................................23 It is important to communicate these findings to the haematology/ oncology care team, as findings of the eye exam(s) may impact the patient’s treatment. Corneal ARs are not the only risks associated with BLENREP.1 2 3 Understanding a Patient With Relapsed/Refractory Multiple Myeloma Multiple myeloma is a malignancy of the plasma Although currently considered incurable, multiple myeloma 6 cells (PCs), resulting in bone marrow (BM) is treatable infiltration and monoclonal protein in serum and/or urine2 • Due to the relapsing course of multiple myeloma, patients often receive multiple lines of therapy. Most patients receive several courses of therapy that may include: an immunomodulatory agent, a proteasome inhibitor (PI) used in combination with a corticosteroid, or anti-CD38 monoclonal antibodies (mAbs)6,7 Multiple myeloma is the third most common haematological malignancy worldwide, • Advances have been made in the management of multiple myeloma in recent years with an estimated 159,985 new with the introduction of these novel therapies.7 Yet the duration of response, time to multiple myeloma cases progression, and survival get shorter with each successive line of therapy8-10 and 106,105 deaths per year3 • Most patients will eventually progress to relapsed and refractory disease, highlighting the need for new treatments8 • The addition of BLENREP to the therapeutic landscape is an important option for Multiple myeloma is most frequently diagnosed patients who have received at least four prior therapies and whose disease is refractory in older individuals, 72 YRS with a median age at to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 4 diagnosis of 72 years 65 74 monoclonal antibody, and who have demonstrated disease progression on the last therapy1,6,7 The highest age-standardised death and incidence rates of multiple myeloma have been observed in countries in Australasia, North America, and Western Europe, while Asia, Oceania, and sub-Saharan Africa are regions with the lowest age-standardised incidence of multiple myeloma5 The content contained within this section is not specific to product indication and is intended to provide general disease state background on multiple myeloma. 4 5 Overview of BLENREP BLENREP, the first BCMA-targeting antibody-drug DREAMM-2 study design overview conjugate for relapsed/refractory multiple myeloma DREAMM-2 (Study 205678) was an open-label, 2-arm, phase II, multicentre study, BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult which evaluated BLENREP as monotherapy in heavily pretreated patients with 1 patients, who have received at least four prior therapies and whose disease is refractory to at multiple myeloma. least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.1 Study Population1,14 BLENREP specifically binds to B-cell maturation antigen (BCMA), a cell-surface protein expressed • Relapsed/refractory multiple myeloma patients, N=97 on myeloma cells, late-stage B cells, and plasma cells. BLENREP binds to cell surface BCMA and is • ≥3 prior lines of therapyª and who were refractory to an immunomodulatory agent, a proteasome inhibitor, and an rapidly internalised. Once inside the tumour cell, free cytotoxic agent (cys-mcMMAF) is released, anti-CD38 antibody alone or in combination 1,11,12 disrupting the microtubule network, leading to cell cycle arrest and apoptosis. • Had undergone autologous HSCT or were considered ineligible • Patients with pre-existing eye conditions, including mild The antibody enhances recruitment and activation of immune effector cells, killing tumour punctate keratopathy, were not excluded from the study, cells by antibody-dependent cellular cytotoxicity and phagocytosis. Apoptosis induced by with the exception of patients with current corneal epithelial disease BLENREP is accompanied by markers of immunogenic cell death (ICD), which may contribute 1,11,12 to an adaptive immune response to tumour cells. Dosing1,14 • 2.5 mg/kg BLENREP as a single agent by intravenous infusion 1 ≥30 min Multiple mechanisms of action • Administered over at least 30 minutes, every 3 weeks • Treatment continued until disease progression or unacceptable toxicity • Dose was modied or discontinued in Delivers cytotoxic payload some cases of ARs Primary Endpoint1,14 Secondary Endpoints14 • Overall response rate • Duration of response • Time to rst response • Progression-free survival Enhances immune-mediated actions • Overall survival • Safety aThe BLENREP indication requires at least 4 prior therapies.1 HSCT=hematopoietic stem cell transplantation. Induces immunogenic cell death BLENREP may have an effect on healthy cells.13 6 7 Adverse reactions (ARs) Efficacy of BLENREP in Patients With ARs (Any Grade) Reported in DREAMM-2 (Study 205678); (N=95)a,1 Relapsed/Refractory Multiple Myeloma1 System Organ Class Adverse Reactions Any Grade (%) Grade 3/4 (%) b Infections and Pneumonia (n=95)11 7 infestations Upper respiratory tract infection 9 0 32% overall response rate in a heavily pretreated patient population Thrombocytopeniac 38 22 Anaemia 27 21 Blood and lymphatic Lymphopeniad 20 17 Depth and durability of responses observed in a patient population with a median 7 lines system disorders Leukopeniae 17 6 1 of prior therapy Neutropeniaf 15 11 (N=95) 58% g of responding Keratopathy 71 31 sCR=2 patients had VGPR Blurred vision eventsh 25 4 Overall CR=3 or better response1 100% i response rate Overall response rate Dry eye events 15 1 Eye disorders Photophobia 4 0 32%VGPR=13 (31/97; 97.5% CI: 22%, 44%) Eye irritation 3 0 Ulcerative keratitis 1 1 80%32% Median 13 months of follow-up (31/97; 97.5% CI: Infective keratitis 1 1 22%, 44%)1 Nausea 25 0 N=97 Gastrointestinal disorders Diarrhoea 13 1 PR=12 Median duration 58% of response 60% of responding patients Vomiting 7 2 11 months had very good partial General disorders and Pyrexia 23 4 (95% CI: 4.2, response or better administration site conditions CR=complete response; not reached) Fatigue 16 2 PR=partial response; Increased aspartate aminotransferase 21 2 40%sCR=stringent complete response; N=30 VGPR=very good partial response. Investigations Increased gamma glutamyltransferase 11 3 2 Patients Stringent complete response Increased creatine phosphokinase 5 2 Injury, poisoning, and 5 Patients Complete response Infusion-related reactionsj 21 3 procedural complications 20% 11 Patients Very good partial response aAdverse reactions coded using MedDRA and graded for hIncludes diplopia, vision blurred, visual acuity reduced, and 13 Patients Partial response severity based on Common Terminology Criteria for Adverse visual impairment. Events (CTCAE v4.03). iIncludes dry eye, ocular discomfort, and eye pruritus. b 0% N=31 Includes pneumonia and herpes simplex pneumonia. jIncludes events determined by investigators to be related to cIncludes thrombocytopenia and decreased platelet count. infusion. Infusion reactions may include, but are not limited dIncludes lymphopenia and decreased lymphocyte count. to, pyrexia, chills, diarrhoea, nausea, asthenia, hypertension, lethargy, and tachycardia. • Clinical benefit rate (sCR + CR + VGPR + PR + minimal response) eIncludes leukopenia and decreased leukocyte count. f was 36% (95% CI: 26.6, 46.5)1 Includes neutropenia and decreased neutrophil count. gBased on eye examination, characterised as corneal epithelium changes with or without symptoms. • Median time to first response • Median time to best response • Median overall survival was 1.5 months (95% CI: 1.0, 2.1)1 was 2.2 months (95% CI: 1.5, 3.6)1 was 13.7 months (95% CI: 9.9, not reached)1 These are not all the possible ARs of BLENREP. If your patient experiences any ARs while taking BLENREP, please tell your patient to contact the haematologist/oncologist. 8 9 Corneal ARs Observed in the DREAMM-2 (Study 205678) Clinical Trial1 Keratopathy or microcyst-like epithelial changes were the BLENREP is an antibody-drug conjugate linking a most common ARs monoclonal antibody with mafodotin, a toxic payload with known corneal ARs1,12,15-17 • Keratopathy or microcyst-like epithelial changes (MECs) were characterised as changes in corneal epithelium
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