Evidence map›Paper›PMID 32712806›Full record

ArticleOphthalmology and therapy2020

Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.

Asim V Farooq, Simona Degli Esposti, Rakesh Popat, Praneetha Thulasi, Sagar Lonial, Ajay K Nooka, Andrzej Jakubowiak, Douglas Sborov, Brian E Zaugg, Ashraf Z Badros and 8 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03525678 (A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody), which is not on this map. Cited by 102 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 3 pooled it
13.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03525678 phase2completednot on this map

A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2024Enrolled221ConditionsMultiple MyelomaArmsBelantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 3 syntheses or guidelines pooled it, 169 citations in OpenAlex.

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42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 2 countries.

Asim V FarooqUniversity of Chicago Medical Center, Chicago, IL, USA. afarooq@bsd.uchicago.edu.
Simona Degli EspostiNIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.
Rakesh PopatUniversity College London Hospitals, NHS Foundation Trust, London, UK.
Praneetha ThulasiEmory Eye Center, Emory University, Atlanta, GA, USA.
Sagar LonialEmory University, Winship Cancer Institute, Atlanta, GA, USA.
Ajay K NookaEmory University, Winship Cancer Institute, Atlanta, GA, USA.
Andrzej JakubowiakUniversity of Chicago Medical Center, Chicago, IL, USA.
Douglas SborovHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
Brian E ZauggMoran Eye Center, University of Utah, Salt Lake City, UT, USA.
Ashraf Z BadrosUniversity of Maryland School of Medicine, Baltimore, MD, USA.
Bennie H JengDepartment of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.
Natalie S CallanderUniversity of Wisconsin, Carbone Cancer Center, Madison, WI, USA.
Joanna OpalinskaGlaxoSmithKline, Upper Providence, PA, USA.
January BaronGlaxoSmithKline, Upper Providence, PA, USA.
Trisha PiontekGlaxoSmithKline, Upper Providence, PA, USA.
Julie ByrneGlaxoSmithKline, Upper Providence, PA, USA.
Ira GuptaGlaxoSmithKline, Upper Providence, PA, USA.
Kathryn ColbyUniversity of Chicago Medical Center, Chicago, IL, USA.
GlaxoSmithKline (United States) · USUniversity of Chicago Medical Center · USProvidence College · USUniversity of Maryland, Baltimore · USEmory Eye Center · USEmory University · USEye Institute of Utah · USMoorfields Eye Hospital NHS Foundation Trust · GBUniversity College London · GBUniversity of Utah · USUniversity of Wisconsin Carbone Cancer Center · USWinship Cancer Institute

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with relapsed or refractory multiple myeloma (RRMM) represent an unmet clinical need. Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class antibody-drug conjugate (ADC; or immunoconjugate) that delivers a cytotoxic payload, monomethyl auristatin F (MMAF), to myeloma cells. In the phase II DREAMM-2 study (NCT03525678), single-agent belamaf (2.5 mg/kg) demonstrated clinically meaningful anti-myeloma activity (overall response rate 32%) in patients with heavily pretreated disease. Microcyst-like epithelial changes (MECs) were common, consistent with reports from other MMAF-containing ADCs.

methodsCorneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected. A literature review on corneal events reported with other ADCs was performed.

resultsIn most patients receiving single-agent belamaf (72%; 68/95), MECs were observed by slit lamp microscopy early in treatment (69% had their first event by dose 4). However, IVCM revealed hyperreflective material. Blurred vision (25%) and dry eye (15%) were commonly reported symptoms. Management of MECs included dose delays (47%)/reductions (25%), with few patients discontinuing due to MECs (1%). The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date. A literature review confirmed that similar MECs were reported with other ADCs; however, event management strategies varied. The pathophysiology of MECs is unclear, though the ADC cytotoxic payload may contribute to on- or off-target effects on corneal epithelial cells.

conclusionSingle-agent belamaf represents a new treatment option for patients with RRMM. As with other ADCs, MECs were observed and additional research is warranted to determine their pathophysiology. A multidisciplinary approach, involving close collaboration between eye care professionals and hematologist/oncologists, is needed to determine appropriate diagnosis and management of these patients.

trial registrationClinicalTrials.gov Identifier, NCT03525678.

Indexed as

Antibody–drug conjugateBelantamab mafodotinCorneaIn vivo confocal microscopyMicrocyst-like epithelial changesMonomethyl auristatin FMultiple myelomaOncology

Identifiers

PMID32712806
PMCPMC7708586
OpenAlexW3044244229

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.