Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze III, multicentrická studie, srovnávací studie
PubMed
38828951
DOI
10.1056/nejmoa2403407
Knihovny.cz E-zdroje
- MeSH
- bortezomib aplikace a dávkování škodlivé účinky MeSH
- chemorezistence MeSH
- dexamethason * aplikace a dávkování škodlivé účinky MeSH
- doba přežití bez progrese choroby * MeSH
- dospělí MeSH
- humanizované monoklonální protilátky * aplikace a dávkování škodlivé účinky MeSH
- Kaplanův-Meierův odhad MeSH
- lenalidomid aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru diagnóza farmakoterapie mortalita MeSH
- mnohočetný myelom * diagnóza farmakoterapie mortalita MeSH
- oční nemoci chemicky indukované epidemiologie MeSH
- progrese nemoci MeSH
- protokoly protinádorové kombinované chemoterapie * aplikace a dávkování škodlivé účinky MeSH
- recidiva MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- thalidomid * aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- belantamab mafodotin MeSH Prohlížeč
- bortezomib MeSH
- dexamethason * MeSH
- humanizované monoklonální protilátky * MeSH
- lenalidomid MeSH
- pomalidomide MeSH Prohlížeč
- thalidomid * MeSH
BACKGROUND: Triplet or quadruplet therapies incorporating proteasome inhibitors, immunomodulators, and anti-CD38 antibodies have led to prolonged survival among patients with newly diagnosed multiple myeloma; however, most patients have a relapse. Frontline lenalidomide therapy has increased the number of patients with lenalidomide-refractory disease at the time of the first relapse. METHODS: In this phase 3, randomized, open-label trial, we evaluated belantamab mafodotin, pomalidomide, and dexamethasone (BPd), as compared with pomalidomide, bortezomib, and dexamethasone (PVd), in lenalidomide-exposed patients who had relapsed or refractory myeloma after at least one line of therapy. The primary end point was progression-free survival. Disease response and safety were also assessed. RESULTS: A total of 302 patients underwent randomization; 155 were assigned to the BPd group, and 147 to the PVd group. At a median follow-up of 21.8 months (range, <0.1 to 39.2), the 12-month estimated progression-free survival with BPd was 71% (95% confidence interval [CI], 63 to 78), as compared with 51% (95% CI, 42 to 60) with PVd (hazard ratio for disease progression or death, 0.52; 95% CI, 0.37 to 0.73; P<0.001). Data on overall survival were immature. The percentage of patients with a response to treatment (partial response or better) was 77% (95% CI, 70 to 84) in the BPd group and 72% (95% CI, 64 to 79) in the PVd group; 40% (95% CI, 32 to 48) and 16% (95% CI, 11 to 23), respectively, had a complete response or better. Grade 3 or higher adverse events occurred in 94% of the patients in the BPd group and 76% of those in the PVd group. Ocular events occurred in 89% of the patients who received BPd (grade 3 or 4 in 43%) and 30% of those who received PVd (grade 3 or 4 in 2%); ocular events in the BPd group were managed with belantamab mafodotin dose modification. Ocular events led to treatment discontinuation in 9% of the patients in the BPd group and in no patients in the PVd group. CONCLUSIONS: Among lenalidomide-exposed patients with relapsed or refractory myeloma, BPd conferred a significantly greater benefit than PVd with respect to progression-free survival, as well as deeper, more durable responses. Ocular events were common but were controllable by belantamab mafodotin dose modification. (Funded by GSK; DREAMM-8 ClinicalTrials.gov number, NCT04484623; EudraCT number, 2018-004354-21.).
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