Blinatumomab reduces toxicity in the consolidation phase in paediatric high-risk B-cell ALL

Paediatric participants with high-risk B-cell acute lymphocytic leukaemia (ALL) who were treated with blinatumomab consolidation therapy displayed fewer adverse events than participants who received intensive chemotherapy in the consolidation phase, the phase 3 AIEOP-BFM ALL 2017 trial showed. Future analyses need to establish whether blinatumomab is non-inferior to chemotherapy regarding anti-leukaemia efficacy.

The current analysis of the phase 3 AIEOP-BFM ALL 2017 trial (NCT03643276), included 549 participants with high-risk ALL who were treated with 2 cycles of either blinatumomab or chemotherapy in the consolidation phase. For central nervous system prophylaxis, 2 intrathecal injections of methotrexate were given on days 1 and 29 of each blinatumomab course, respectively. The research question was whether treatment-related, life-threatening complications and mortality during the intensified consolidation phase of high-risk treatment could be reduced if 2 intensive chemotherapy courses were replaced by 2 courses of immunotherapy with blinatumomab. Prof. Martin Schrappe (Hong Kong College of Paediatricians, China) presented the findings [1].

The rate of participants experiencing medically relevant adverse reactions of special interest (ARSI) was significantly higher in the chemotherapy arm than in the immunotherapy arm (22.8% vs 10.3%; P<0.001). Importantly, life-threatening ARSI occurred in 5.2% of participants receiving chemotherapy but were non-existent in participants on blinatumomab (P<0.001). Particularly, the rates of infections (7.5% vs 0.4%) and immune system disorders (10.1% vs 2.5%) were higher in participants receiving chemotherapy. Finally, nervous system disorders were more common in the blinatumomab arm (7.5% vs 2.2%) and the opposite trend was observed for gastrointestinal disorders (2.2% vs 0%, chemotherapy vs blinatumomab).

“The toxicity profile of blinatumomab was much more favourable compared with the intensive chemotherapy approach. If upcoming analyses of outcome data in the AIEOP-BFM ALL 2017 trial show non-inferiority of the experimental arm in terms of efficacy, blinatumomab replacement of some of the intensive chemotherapy blocks will become the new standard-of-care for patients with newly diagnosed high-risk B-cell ALL,” concluded Prof. Schrappe.

1. Schrappe M, et al. Pediatric patients with high-risk B-cell ALL in first complete remission may benefit from less toxic immunotherapy with blinatumomab - results from randomized controlled phase 3 trial AIEOP-BFM ALL 2017. Abstract 825, 65^th ASH Annual Meeting, 9–12 December 2023, San Diego, CA, USA.

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Posted on 7 February 202428 March 2024