Efficacy and safety of blinatumomab: Post hoc pooled analysis in Asian adults with relapsed/refractory B‐cell precursor acute lymphoblastic leukemia. Issue 3 (29th June 2021)

• Record Type: Journal Article
• Authors: Kobayashi, Yukio; Oh, Iekuni; Miyamoto, Toshihiro; Lee, Won‐Sik; Iida, Hiroatsu; Minami, Hironobu; Maeda, Yoshinobu; Jang, Jun Ho; Yoon, Sung‐Soo; Yeh, Su‐Peng; Tran, Qui; Morris, Joan; Franklin, Janet; Kiyoi, Hitoshi
• Is Part Of: Asia-Pacific journal of clinical oncology. Volume 18:Issue 3(2022)
• Page Start: 311
• Page End: 318
• Publication Date: 2021-06-29
• Subjects: acute lymphoblastic leukemia (ALL) -- Asia -- blinatumomab -- post hoc analysis -- relapsed/refractory; Oncology -- Pacific Area -- Periodicals; Cancer -- Treatment -- Pacific Area -- Periodicals; Cancer -- Pacific Area -- Periodicals; Cancer -- Treatment -- Periodicals; 616.9940095
• DOI: 10.1111/ajco.13609
• Languages: English
• ISSNs: 1743-7555

Abstract

Abstract: Background: Global studies have demonstrated the efficacy and safety of blinatumomab—a BiTE ® (bispecific T‐cell engager) targeted immuno‐oncology therapy that mediates the lysis of cells expressing CD19 in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL). Because limited data are available in Asian patients, we conducted a post hoc pooled analysis in 45 Asian adult patients with R/R ALL—19 from the blinatumomab arm of TOWER (NCT02013167) and 26 from Study 265, a phase 1b/2 study in Japanese adults (NCT02412306). Methods: Patients received a maximum of two cycles of induction blinatumomab for 4 weeks by continuous intravenous infusion (cycle 1/week 1: 9 μg/day; cycle 1/weeks 2–4: 28 μg/day) followed by 2 weeks of no blinatumomab (each 6‐week cycle); patients received 28 μg/day blinatumomab in subsequent cycles. Results: Twenty of 45 patients enrolled (44%) achieved complete remission with full or partial hematologic recovery compared with 44% in TOWER and 80% and 38% in phase 1b and phase 2, respectively, of Study 265. The Kaplan–Meier (KM) median overall survival was 11.9 months (95% confidence interval [CI], 9.9–17.1) and the KM median duration of relapse‐free survival was 8.9 months (95% CI, 3.8–10.7). Ninety‐three percent of patients had grade ≥ 3 treatment‐emergent adverse events (AEs) compared with 87% in TOWER and 80% and 100% in phase 1b and phase 2, respectively, of Study 265. Five patients (11.4%) had fatal AEs. Conclusions: The safety and efficacy of blinatumomab in Asian patients were comparable with those reported in previous global studies with no new safety signals. Abstract : The objective of this post hoc subgroup analysis was to assess the safety and efficacy of blinatumomab in Asian patients with relapsed/refractory acute lymphoblastic leukemia drawn from the global TOWER study and Study 265, a phase 1b/2 study in Japanese adults. The safety and efficacy of blinatumomab in Asian patients were comparable with those reported in TOWER and Study 265, with similar disease response rates and no new safety concerns.