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DREAMM-11, Part 2: Japanese phase I trial of belantamab mafodotin combination therapies in relapsed/refractory

Kazutaka Sunami1, Shinsuke Iida2, Nobuhiro Tsukada3

  • 1Department of Hematology, NHO Okayama Medical Center, 1711-1 Tamasu Kitaku, Okayama, Japan. kazusuna@pop12.odn.ne.jp.

International Journal of Hematology
|December 24, 2024
PubMed

Insights

Belantamab mafodotin combined with standard therapies showed promising safety and efficacy in Japanese patients with relapsed/refractory multiple myeloma (RRMM). Treatment combinations were well-tolerated, with high response rates observed.

Area of Science:

  • Oncology
  • Hematology
  • Clinical Pharmacology

Background:

  • Relapsed/refractory multiple myeloma (RRMM) presents a significant challenge in treatment, necessitating novel therapeutic strategies.
  • Belantamab mafodotin, an antibody-drug conjugate, has shown promise in multiple myeloma treatment.
  • Japanese populations require specific clinical evaluation for novel therapies due to potential pharmacokinetic and pharmacodynamic differences.

Purpose of the Study:

  • To evaluate the safety, tolerability, clinical activity, and pharmacokinetics of belantamab mafodotin in combination regimens in Japanese patients with RRMM.
  • To assess belantamab mafodotin plus bortezomib and dexamethasone (Arm A) and belantamab mafodotin plus pomalidomide and dexamethasone (Arm B).

Main Methods:

  • Phase 1, open-label, dose-escalation study (DREAMM-11, NCT03828292) in Japanese patients with RRMM.
  • Part 1: Belantamab mafodotin monotherapy. Part 2: Combination therapies with specific dosing schedules for belantamab mafodotin, bortezomib, dexamethasone, or pomalidomide.
  • Safety, tolerability, overall response rate (ORR), and pharmacokinetic analyses were performed.

Main Results:

  • Belantamab mafodotin monotherapy was tolerated with clinical activity and a manageable safety profile in Part 1.
  • In Part 2, Arm A (N=3) showed no dose-limiting toxicities and 100% ORR. Arm B (N=4) reported one non-serious liver injury and 50% ORR.
  • Safety profiles were consistent with individual agents and Western populations. Pharmacokinetics were similar between Japanese and Western patients.

Conclusions:

  • Belantamab mafodotin in combination with bortezomib/dexamethasone or pomalidomide/dexamethasone demonstrated acceptable safety and notable clinical activity in Japanese patients with RRMM.
  • The findings support the potential utility of these belantamab mafodotin-based regimens for Japanese RRMM patients.
  • Pharmacokinetic data suggest no significant differences between Japanese and Western populations, supporting broader applicability.
Keywords:
B-cell maturation antigenBelantamab mafodotinCombination therapyJapanRelapsed/refractory multiple myeloma

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