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
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) |
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2022 ASCO Annual Meeting
First Author: Malin Hultcrantz
2022 ASCO Annual Meeting
First Author: Andrew Spencer
2020 ASCO Virtual Scientific Program
First Author: Sagar Lonial
2023 ASCO Annual Meeting
First Author: Dan T. Vogl