OnCo
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COG AALL1731

In children with average-risk leukaemia, adding blinatumomab pushed three-year disease-free survival from 88% to 96%, one of the largest gains in decades.

1,440 randomised children with standard-risk average or high subsets. 3-year DFS 96.0% vs 87.9% (HR 0.39, 95% CI 0.24-0.64); randomisation stopped early for efficacy. NEJM 2024. Led to FDA approval of blinatumomab in the consolidation phase for CD19+ Ph-negative B-ALL in children (June 2024) and is being adopted as the new paediatric standard.

Setting
Newly diagnosed standard-risk B-ALL in children: two cycles of blinatumomab added to chemotherapy vs chemotherapy alone
Phase
Phase 3
Sponsor
Children's Oncology Group / NCI
Registry
Headline result
3-year DFS 96.0% vs 87.9%; HR 0.39.
Reported
2024
Enrolled
1440
Replication
Consistent with E1910 in adults; the paediatric MRD-positive blinatumomab trials (AALL1331, IntReALL HR 2010) had shown benefit in relapse earlier.

Outcomes

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In plain words
What these results mean for people, not percentages
1,440 people took part
Disease-free survival at 3 yearsprimarysurrogate endpoint
  • 96 vs 87.9 out of 100 alive without the cancer coming back at 3 years with Blinatumomab + chemotherapy compared with Chemotherapy; 8.1 more per 100.
  • Roughly one extra person helped for every 12 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 61 percent lower chance of the event at any given time (hazard ratio 0.39, likely range 0.24 to 0.64).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Newly diagnosed standard-risk B-ALL in children: two cycles of blinatumomab added to chemotherapy vs chemotherapy alone. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,440 participants enrolled.

Disease-free survival at 3 yearsprimary
HR 0.39 (0.24–0.64) · p <0.001
Blinatumomab + chemotherapy96 of 100
n = 722
Chemotherapy87.9 of 100
n = 718
Source
EndpointArmnValueHR (95% CI)pSource
Disease-free survival at 3 yearsprimaryBlinatumomab + chemotherapy72296%0.39 (0.24–0.64)<0.001link
Chemotherapy71887.9%
Replication
Consistent with E1910 in adults; the paediatric MRD-positive blinatumomab trials (AALL1331, IntReALL HR 2010) had shown benefit in relapse earlier.

Key papers

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Connected

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