Gil-Sierra Manuel David, Briceño-Casado Maria Del Pilar
Pharmacy Department, Hospital Universitario Puerto Real, Ctra. N-IV Km. 665, 11510 Puerto Real, Cadiz, Spain.
Department of Pharmacology, Universidad de Sevilla, Facultad de Farmacia, Calle Profesor García González 2, 41012, Sevilla, Spain.
J Oncol Pharm Pract. 2022 Sep;28(6):1375-1380. doi: 10.1177/10781552221086265. Epub 2022 Mar 21.
Refractory multiple myeloma (MM) presents poor responses to therapies. New drugs for highly pretreated MM are a hope for this clinical context with limited treatment options. We developed a comparative commentary on the evidence about the use of belantamab mafodotin in heavily pretreated relapsed or refractory MM with respect to other therapies. Regimen data were extracted from pivotal clinical trials. Response rates were the main efficacy outcomes reported in trials. Overall response was achieved by approximately 30% of patients trated with belantamab mafodotin. Response rates of different regimens must be supported by more relevant data, such as overall survival or progression-free survival. Subgroups of patients with extramedullary disease and revised International Staging System III should be thoroughly evaluated in phase III comparative clinical trials with larger sample sizes. Belantamab mafodotin presented specific adverse events (visual disturbances and kerathopathies). Grade 3-4 adverse events involved high percentages of patients treated with the different schemes. The budgetary impact of different treatments for heavily pretreated refractory MM would be very high. Literature suggested increased efficiency of belantamab mafodotin versus chimeric antigen receptor T-cell therapies. Belantamab mafodotin and other regimens are promising drugs for MM, especially for triple-class refractory patients. Comparative studies are necessary to perform a reliable therapeutic positioning.
难治性多发性骨髓瘤(MM)对治疗反应不佳。对于治疗选择有限的这种临床情况而言,用于高度预处理MM的新药带来了希望。我们针对与其他疗法相比,贝兰他单抗马福多汀在高度预处理的复发或难治性MM中的应用证据进行了比较性评论。方案数据从关键临床试验中提取。缓解率是试验中报告的主要疗效结果。接受贝兰他单抗马福多汀治疗的患者中约30%实现了总体缓解。不同方案的缓解率必须有更多相关数据支持,如总生存期或无进展生存期。在样本量更大的III期比较临床试验中,应彻底评估伴有髓外疾病和修订的国际分期系统III期的患者亚组。贝兰他单抗马福多汀出现了特定不良事件(视觉障碍和角膜病变)。3-4级不良事件在接受不同方案治疗的患者中占比很高。对于高度预处理的难治性MM,不同治疗的预算影响将非常高。文献表明,与嵌合抗原受体T细胞疗法相比,贝兰他单抗马福多汀的疗效有所提高。贝兰他单抗马福多汀和其他方案是治疗MM的有前景的药物,尤其是对于三重耐药患者。进行可靠的治疗定位需要进行比较研究。