Patient-reported outcomes (PROs) from the DREAMM-7 randomized phase 3 study comparing belantamab mafodotin, bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM).

Authors

null

Vania Hungria

Clinica São Germano, São Paulo, Brazil

Vania Hungria , Pawel Robak , Marek Hus , Chengcheng Fu , Vera Zherebtsova , Christopher Ward , Ana Carolina de Almeida , P. Joy Ho , Roman Hajek , Claudio Cerchione , Nicholas Pirooz , Astrid McKeown , Hena Baig , Lydia Eccersley , Farrah Pompilus , Simon McNamara , Chee Paul Lin , Sumita Roy-Ghanta , Joanna Opalinska , Maria-Victoria Mateos

Organizations

Clinica São Germano, São Paulo, Brazil, Medical University of Lodz, Lodz, Poland, Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland, The First Affiliated Hospital of Soochow University, Suzhou, China, Gorodskaya Klinicheskaya Bol'nitsa Im. S.; Botkina, Moscow, Russian Federation, Royal North Shore Hospital, Sydney, Australia, Centro de Pesquisa e Ensino em Saude de Santa Catarin, Florianopolis, Brazil, Royal Prince Alfred Hospital, Camperdown, NSW, Australia, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic, Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy, GSK Research and Development Upper Providence, Collegeville, PA, GSK, Stevenage, United Kingdom, GSK plc, Mississauga, ON, Canada, GSK, London, United Kingdom, GSK, Boston, MA, GSK, Upper Providence, PA, Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Centro de Investigación del Cáncer (IBMCC-USAL, CSIC), Salamanca, Spain

Research Funding

GSK plc

Background: Belantamab mafodotin(belamaf), a first-in-class antibody-drug conjugate targeting B-cell maturation antigen, acts through a multimodal mechanism including direct cell killing and immune-mediated mechanisms. The global, phase 3, open-label, randomized, DREAMM-7 trial (NCT04246047) met its primary endpoint of demonstrating statistically significant progression-free survival benefit favoring BVd vs DVd in patients with RRMM who had received ≥1 prior line of therapy; here, we report PRO findings for BVd vs DVd. Methods: Patients were randomized (1:1) to receive BVd or DVd and completed electronic PRO measures at baseline and every 3 weeks (Q3W) during treatment. PRO measures included EORTC-QLQ-C30, EORTC-QLQ-MY20 disease symptoms (pain), PRO-CTCAE patient-reported tolerability, and OSDI vision-related functioning (Q3W up to the sixth dose of belamaf, then Q6W). Each domain was summarized using descriptive statistics. Results: Among 494 patients (BVd, n=243; DVd, n=251), adherence to PRO assessments was >90% for most study visits. There was no difference in EORTC QLQ-C30 global health status/quality-of-life assessments between the study arms over time. Similarly, role functioning, physical functioning, fatigue, and pain were stable (change from baseline in EORTC score was within 10 points) over time and consistent between arms. Most symptomatic adverse events evaluated by PRO-CTCAE were reported at no to low severity, frequency, and interference (PRO-CTCAE ratings ≤2) in both arms throughout the study. The severity and interference of blurred vision and frequency of watery eyes were reported at higher levels (PRO-CTCAE ratings ≥3) in the BVd arm. Among patients in the BVd arm with a clinically meaningful deterioration in vision-related functioning (a change from baseline of ≥12.5 points), EORTC-QLQ-C30 global health status, role functioning, and physical functioning were comparable to the DVd arm over time. Conclusions: Overallquality of life, role functioning, physical functioning, fatigue, and pain were comparable in patients treated with BVd vs DVd. In patients treated with BVd who reported a clinically meaningful deterioration in vision-related functioning, overall quality of life was consistent with the DVd arm.

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Abstract Details

Meeting

2024 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Plasma Cell Dyscrasia

Track

Hematologic Malignancies

Sub Track

Multiple Myeloma

Citation

J Clin Oncol 42, 2024 (suppl 16; abstr 7543)

DOI

10.1200/JCO.2024.42.16_suppl.7543

Abstract #

7543

Poster Bd #

180

Abstract Disclosures