Sunami Kazutaka, Iida Shinsuke, Tsukada Nobuhiro, Fujii Taku, Kato Hitomi, Fukushima Ryuichi, Wakabayashi Satoshi, Nakano Hirofumi, Roy-Ghanta Sumita, Kremer Brandon E
Department of Hematology, NHO Okayama Medical Center, 1711-1 Tamasu Kitaku, Okayama, Japan.
Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan.
Int J Hematol. 2025 Feb;121(2):174-186. doi: 10.1007/s12185-024-03889-8. Epub 2024 Dec 24.
DREAMM-11 (NCT03828292) was a Phase 1, open-label, dose-escalation study of belantamab mafodotin in Japanese patients with relapsed/refractory multiple myeloma (RRMM). In Part 1, belantamab mafodotin monotherapy (2.5 or 3.4 mg/kg every 3 weeks) was tolerated and demonstrated clinical activity and a manageable safety profile. Part 2 investigated the tolerability, safety, clinical activity and pharmacokinetics of belantamab mafodotin (2.5 mg/kg on Day [D]1 of each 21-day cycle) plus bortezomib and dexamethasone (Arm A; N = 3) or belantamab mafodotin (2.5 mg/kg on D1 of the first 28-day cycle; 1.9 mg/kg on D1 of subsequent cycles) plus pomalidomide and dexamethasone (Arm B; N = 4) in Japanese patients with RRMM and ≥ 1 prior line of therapy. No dose-limiting toxicities were reported in Arm A; 1 (non-serious liver injury) was reported in Arm B. Safety profiles of each treatment combination were consistent with those of the individual agents and those in Western populations. An overall response was achieved by 3/3 (100%) patients in Arm A and 2/4 (50%) in Arm B. Pharmacokinetics were consistent between Japanese and Western populations. The clinical pharmacokinetics, safety, and efficacy data from this study can inform future use of belantamab mafodotin plus bortezomib/pomalidomide and dexamethasone in Japanese patients with RRMM.
DREAMM-11（NCT03828292）是一项针对日本复发/难治性多发性骨髓瘤（RRMM）患者开展的1期开放标签剂量递增研究，研究药物为贝兰他单抗莫福汀。在第1部分中，贝兰他单抗莫福汀单药治疗（每3周2.5或3.4mg/kg）耐受性良好，显示出临床活性且安全性可控。第2部分研究了贝兰他单抗莫福汀（每21天周期的第1天[D1]给予2.5mg/kg）联合硼替佐米和地塞米松（A组；N = 3）或贝兰他单抗莫福汀（第1个28天周期的D1给予2.5mg/kg；后续周期的D1给予1.9mg/kg）联合泊马度胺和地塞米松（B组；N = 4）在接受过≥1线既往治疗的日本RRMM患者中的耐受性、安全性、临床活性和药代动力学。A组未报告剂量限制性毒性；B组报告了1例（非严重肝损伤）。每种治疗组合的安全性特征与各单药以及西方人群中的安全性特征一致。A组3/3（100%）的患者和B组2/4（50%）的患者获得了总体缓解。日本人群和西方人群的药代动力学一致。本研究的临床药代动力学、安全性和疗效数据可为未来贝兰他单抗莫福汀联合硼替佐米/泊马度胺和地塞米松用于日本RRMM患者提供参考。
