From Clinica São Germano (V.H.) and Hospital das Clínicas and Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo (G.A.M.), São Paulo, Centro de Pesquisa e Ensino em Saúde de Santa Catarin, Florianópolis (A.C.R.A.), and Universidade da Região de Joinville and Centro de Hematologia e Oncologia, Joinville (M.P.L.) - all in Brazil; Medical University of Lodz, Lodz (P.R.), Medical University of Lublin, Lublin (M.H., M.M.), and the Medical University of Silesia, Katowice (S.G.) - all in Poland; Gorodskaya Klinicheskaya Bol'nitsa Imeni Saint Petersburg Botkina, Moscow (V.Z.); the Royal North Shore Hospital (C.W.) and Liverpool Hospital (A.B.), Sydney, Royal Prince Alfred Hospital and University of Sydney, Camperdown, NSW (P.J.H.), and Pindara Private Hospital, Gold Coast, QLD (H.S.) - all in Australia; the Department of Hematooncology, University Hospital Ostrava, and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic (R.H.); Sungkyunkwan University and Samsung Medical Center, Seoul, South Korea (K.K.); Institut Català d'Oncologia-L'Hospitalet de Llobregat-Barcelona, Barcelona (A.M.S.B.), Institut Català d'Oncologia and Josep Carreras Research Institute, Hospital Germans Trias i Pujol, Badalona (A.O.), and Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Centro de Investigación del Cáncer, Ciberonc, Salamanca (M.-V.M.) - all in Spain; Cross Cancer Institute, Edmonton (I.S.), and GSK, Mississauga (H.B.) - both in Canada; the Hematology Unit, Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori," IRST IRCCS, Meldola (C.C.), and IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Bologna (M.C.) - both in Italy; Christchurch Hospital, Christchurch, New Zealand (P.G.); National and Kapodistrian University of Athens, Athens (M.D.); the First Affiliated Hospital of Soochow University, Suzhou, China (C.F.); University Hospitals of Leicester NHS Trust, Leicester (M.G.), GSK, Stevenage (A.M., S.M.), and GSK, London (L.E.) - all in the United Kingdom; University of Kansas Cancer Center, Fairway (A.-O.A.); the Department of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel (M.E.G.); Rocky Mountain Cancer Centers-Denver-Midtown, Denver (R. Rifkin); Matsuyama Red Cross Hospital, Matsuyama, Japan (T.F.); GSK, Upper Providence, PA (N.P., X.Z., R. Rogers, S.R.-G., J.O.); and GSK, Durham (M.N.), and GSK, Research Triangle Park (E.L.) - both in North Carolina.
N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.
BACKGROUND: Belantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further evaluation of the agent in combination with standard-care therapies. METHODS: In this phase 3, open-label, randomized trial, we evaluated belantamab mafodotin, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary end point was progression-free survival. Key secondary end points were overall survival, response duration, and minimal residual disease (MRD)-negative status. RESULTS: In total, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group and 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. An analysis of the restricted mean response duration favored BVd over DVd (P<0.001). A complete response or better plus MRD-negative status occurred in 25% of the patients in the BVd group and 10% of those in the DVd group. Grade 3 or higher adverse events occurred in 95% of the patients in the BVd group and 78% of those in the DVd group. Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%); such events were managed with dose modifications, and events of worsening visual acuity mostly resolved. CONCLUSIONS: As compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy. Most patients had grade 3 or higher adverse events. (Funded by GSK; DREAMM-7 ClinicalTrials.gov number, NCT04246047; EudraCT number, 2018-003993-29.).
背景：在复发或难治性多发性骨髓瘤患者中，贝兰他单抗mafodotin 单药治疗具有活性，这一发现支持进一步评估该药与标准治疗联合应用。
方法：在这项 3 期、开放性、随机试验中，我们评估了贝兰他单抗 mafodotin、硼替佐米和地塞米松（BVd）与达雷妥尤单抗、硼替佐米和地塞米松（DVd）相比，在至少一线治疗后疾病进展的多发性骨髓瘤患者中的疗效。主要终点是无进展生存期。关键次要终点是总生存期、缓解持续时间和微小残留病灶（MRD）阴性状态。
结果：共有 494 例患者被随机分配接受 BVd（243 例）或 DVd（251 例）治疗。在中位随访 28.2 个月（范围，0.1 至 40.0）时，BVd 组的中位无进展生存期为 36.6 个月（95%置信区间[CI]，28.4 至未达到），DVd 组为 13.4 个月（95%CI，11.1 至 17.5）（疾病进展或死亡的风险比，0.41；95%CI，0.31 至 0.53；P<0.001）。BVd 组 18 个月总生存率为 84%，DVd 组为 73%。分析限制性平均缓解持续时间表明 BVd 优于 DVd（P<0.001）。BVd 组有 25%的患者达到完全缓解或更好，MRD 阴性，DVd 组有 10%的患者达到该标准。BVd 组 95%的患者和 DVd 组 78%的患者发生 3 级或更高级别的不良事件。BVd 组比 DVd 组更常见眼部事件（79% vs. 29%）；这些事件通过剂量调整来管理，视力恶化事件大多得到解决。
结论：与 DVd 治疗相比，BVd 治疗在至少接受过一线治疗后复发或难治性多发性骨髓瘤患者中显著改善了无进展生存期。大多数患者有 3 级或更高级别的不良事件。（由 GSK 资助；DREAMM-7 ClinicalTrials.gov 编号，NCT04246047；EudraCT 编号，2018-003993-29。）
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