Single-agent belantamab mafodotin for relapsed/refractory multiple myeloma: analysis of the lyophilised presentation cohort from the pivotal DREAMM-2 study.
Paul G RichardsonHans C LeeAl-Ola AbdallahAdam David CohenPrashant KapoorPeter M VoorheesAxel HoosKarrie WangJanuary BaronTrisha PiontekJulie ByrneScott RichmondRoxanne C JewellJoanna OpalinskaIra GuptaSagar LonialPublished in: Blood cancer journal (2020)
DREAMM-2 (NCT03525678) is an ongoing global, open-label, phase 2 study of single-agent belantamab mafodotin (belamaf; GSK2857916), a B-cell maturation antigen-targeting antibody-drug conjugate, in a frozen-liquid presentation in patients with relapsed/refractory multiple myeloma (RRMM). Alongside the main study, following identical inclusion/exclusion criteria, a separate patient cohort was enrolled to receive belamaf in a lyophilised presentation (3.4 mg/kg, every 3 weeks) until disease progression/unacceptable toxicity. Primary outcome was independent review committee-assessed overall response rate (ORR). Twenty-five patients were enrolled; 24 received ≥1 dose of belamaf. As of 31 January 2020, ORR was 52% (95% CI: 31.3-72.2); 24% of patients achieved very good partial response. Median duration of response was 9.0 months (2.8-not reached [NR]); median progression-free survival was 5.7 months (2.2-9.7); median overall survival was not reached (8.7 months-NR). Most common grade 3/4 adverse events were keratopathy (microcyst-like corneal epithelial changes, a pathological finding seen on eye examination [75%]), thrombocytopenia (21%), anaemia (17%), hypercalcaemia and hypophosphatemia (both 13%), neutropenia and blurred vision (both 8%). Pharmacokinetics supported comparability of frozen-liquid and lyophilised presentations. Single-agent belamaf in a lyophilised presentation (intended for future use) showed a deep and durable clinical response and acceptable safety profile in patients with heavily pre-treated RRMM.
Keyphrases
- multiple myeloma
- end stage renal disease
- free survival
- newly diagnosed
- open label
- ejection fraction
- case report
- acute myeloid leukemia
- acute lymphoblastic leukemia
- chronic kidney disease
- prognostic factors
- peritoneal dialysis
- randomized controlled trial
- diffuse large b cell lymphoma
- cancer therapy
- signaling pathway
- radiation therapy
- oxidative stress
- study protocol
- ionic liquid
- squamous cell carcinoma
- rectal cancer
- wound healing
- phase iii