Relationship between corneal exam findings, best-corrected visual acuity (BCVA), and ocular symptoms in patients with relapsed or refractory multiple myeloma (RRMM) receiving belantamab mafodotin (belamaf).

Authors

null

Evangelos Terpos

National and Kapodistrian University of Athens School of Medicine, Athens, Greece

Evangelos Terpos , Ashraf Badros , Rakesh Popat , Paula Rodríguez-Otero , Asim Farooq , Bennie Jeng , Simona Degli Esposti , Eric Lewis , Ira Gupta , Joanna Opalinska , Antonio Palumbo , Suzanne Trudel

Organizations

National and Kapodistrian University of Athens School of Medicine, Athens, Greece, University of Maryland School of Medicine, Baltimore, MD, University College London Hospitals, NHS Foundation Trust, London, United Kingdom, Clinica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra, Navarra, Spain, University of Chicago Medical Center, Chicago, IL, NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom, GlaxoSmithKline, Research Triangle Park, NC, GlaxoSmithKline, Upper Providence, PA, GlaxoSmithKline, Zug, Switzerland, Princess Margaret Cancer Centre, Toronto, ON, Canada

Research Funding

Pharmaceutical/Biotech Company
GlaxoSmithKline, Drug linker technology licensed from Seagen Inc.; mAb produced using POTELLIGENT Technology licensed from BioWa

Background: Belantamab mafodotin (GSK2857916; belamaf; BLENREP) is a B-cell maturation antigen (BCMA)-targeting antibody–drug conjugate approved in the US and EU as a monotherapy for the treatment of adult patients with RRMM. Ocular events (OEs) during the pivotal DREAMM-2 trial (NCT03525678) included corneal exam findings (punctate keratopathy and microcyst-like epithelial changes), BCVA changes, and ocular symptoms. Dose reductions or delays based on corneal exam findings and BCVA were used to manage OEs. Here we performed a post hoc investigation of relationships between corneal exam findings, BCVA changes, and patient-reported ocular symptoms to explore if BCVA changes and symptoms could guide dosing, rather than corneal exams. Methods: Eye evaluations (including a corneal exam and BCVA assessment of Snellen visual acuity) were performed on all patients receiving single-agent belamaf (2.5 mg/kg) by ophthalmologists at baseline and prior to each belamaf dose. Changes in the corneal epithelium (Ker) and BCVA were both assessed as per protocol-defined criteria and assessment of grade (Gr) was based on the worse eye. BCVA grading was relative to baseline. Patient-reported ocular symptoms were reported as per the Common Terminology Criteria for Adverse Events. Results: In 12.5% of eye evaluations Gr 3–4 Ker was associated with minimal or no (Gr ≤1) BCVA changes. When patient-reported ocular symptoms were also considered, only 7.5% of evaluations found Gr 3–4 Ker with Gr ≤1 BCVA changes or ocular symptoms. Mild or no (Gr ≤2) Ker was associated with Gr ≤1 BCVA changes in 59.5% of evaluations, or in 38.8% of evaluations with no ocular symptoms reported. Overall, Gr 3–4 Ker were found in 24.9% of evaluations; by contrast, patients had Gr 2–4 BCVA changes or ocular symptoms in 53.7% of evaluations. Association of corneal epithelium changes (Ker) with BCVA changes and ocular symptoms. Conclusions: These findings highlight that BCVA changes and ocular symptoms should be further investigated to determine if they can be used as alternatives (eg, frequency of eye examinations based on symptoms) for the management of belamaf dosing to potentially reduce the burden on patients and healthcare professionals. Clinical trial information: NCT03525678

Ker + BCVA changes only (evaluations, n=773); n (%)

Gr 3–4 Ker & Gr ≤1 BCVA
97 (12.5)
Gr 3–4 Ker & Gr 2–4 BCVA
96 (12.4)
Gr ≤2 Ker & Gr ≤1 BCVA
460 (59.5)
Gr ≤2 Ker & Gr 2–4 BCVA
120 (15.5)
Ker + BCVA changes or ocular symptoms (evaluations, n=773); n (%)

Gr 3–4 Ker & (Gr ≤1 BCVA, no symptoms)
58 (7.5)
Gr 3–4 Ker & (Gr 2–4 BCVA, or symptoms)
135 (17.4)
Gr ≤2 Ker & (Gr ≤1 BCVA, no symptoms)
300 (38.8)
Gr ≤2 Ker & (Gr 2–4 BCVA, or symptoms)
280 (36.2)

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Plasma Cell Dyscrasia

Track

Hematologic Malignancies

Sub Track

Multiple Myeloma

Clinical Trial Registration Number

NCT03525678

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 8033)

DOI

10.1200/JCO.2021.39.15_suppl.8033

Abstract #

8033

Poster Bd #

Online Only

Abstract Disclosures