Survival outcomes in patients with relapsed/refractory or MRD-positive B-cell acute lymphoblastic leukemia treated with blinatumomab.

Blinatumomab has demonstrated significant efficacy in adult and pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-cell ALL) and patients with measurable residual disease (MRD). This review aimed to compare median relapse-free survival (RFS) and median overall survival (OS) in adult and pediatric patients with R/R or MRD-positive B-cell ALL from pivotal studies [MT-103-211 and TOWER for adults with Philadelphia chromosome (Ph)-negative R/R B-cell ALL, ALCANTARA for adults with Ph-positive R/R B-cell ALL, MT-103-203 for adults with MRD-positive B-cell ALL, and MT-103-205 for pediatric patients with R/R B-cell ALL], with the median RFS and OS from retrospective analyses, country or ethnicity-specific studies, and studies based on real-world evidence (RWE) identified from a literature search. Adults with Ph-negative R/R B-cell ALL who received blinatumomab as first salvage demonstrated a numerically longer median OS compared with that in patients from pivotal studies (MT-103-211 and TOWER) without additional safety concerns. In pediatric patients with R/R B-cell ALL treated with blinatumomab, the median RFS and OS from retrospective analyses and country/ethnicity-specific studies were comparable with the median RFS and OS from the pivotal study MT-103-205. The median RFS and OS from RWE studies in adults with R/R B-cell ALL were numerically longer than the median RFS and OS from pivotal studies (MT-103-211, TOWER, and ALCANTARA); however, this trend was not observed in pediatric patients with R/R B-cell ALL. In conclusion, this analysis identified first salvage adults with Ph-negative R/R B-cell ALL as particularly well-suited for treatment with blinatumomab since survival outcomes from retrospective analyses reported in this patient subgroup were numerically better compared with those from pivotal studies without additional safety signals.

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© The Author(s), 2023.

Déclaration de conflit d'intérêts

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: HMK received grant support from Amgen, Pfizer, Bristol-Myers Squibb (BMS), Novartis Pharmaceuticals, and Ariad Pharmaceuticals. ACL received research funding from Autolus, Amphivena, Astellas, Jazz, Kadmon, Kite, Pharmacyclics, and Talaris; consulting fees from AbbVie, Amgen, BMS, and Pfizer; and participated in a data safety monitoring board for Servier. FZ and YZ are employees and hold stocks of Amgen Inc. NG served on an advisory board for Kite Pharma (uncompensated), received fees for serving on advisory boards from Amgen, Pfizer, and Celgene/Juno Therapeutics, received travel support from Amgen and Pfizer, and received grant support from Amgen. RB served as an advisor and received honoraria from Amgen, Cellex, GEMoaB, AstraZeneca, Novartis, and CatalYm; in addition, RB has a patent for blinatumomab with royalties paid. GZ is an employee of, has patents from, and owns stock in Amgen Inc. FL has received personal fees from Amgen, personal fees from Novartis, other from Bellicum Pharmaceutical, other from Neovii, personal fees from Miltenyi, personal fees from Medac, personal fees from Jazz Pharmaceutical, and personal fees from Takeda, outside the submitted work.