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ALFA-0701 was the trial that rescued the first ADC: giving gemtuzumab in three small doses with chemotherapy improved event-free survival without the toxicity that got it withdrawn.
Gemtuzumab 3 mg/m² on days 1, 4, 7. Median EFS 17.3 vs 9.5 months (HR 0.56, 95% CI 0.42-0.76); relapse-free survival improved; OS not significantly different in the final analysis (27.5 vs 21.8 months). Lancet 2012; basis of the 2017 US re-approval. Meta-analysis of five trials confirmed OS benefit in favourable- and intermediate-risk cytogenetics.
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.
280 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (median)primary | GO + 7+3 | 135 | 17.3 months | 0.56 (0.42 to 0.76) | - | link |
| 7+3 | 136 | 9.5 months | ||||
| Overall survival (median) | GO + 7+3 | - | 27.5 months | - | - | link |
| 7+3 | - | 21.8 months |
Shares COG AAML0531, Gemtuzumab ozogamicin.
Shares CD33, Gemtuzumab ozogamicin, Acute myeloid leukaemia.
Shares CD33, Acute myeloid leukaemia, Antibody-drug conjugate (ADC).
Shares CD33, Acute myeloid leukaemia.
Shares Gemtuzumab ozogamicin, Antibody-drug conjugate (ADC).
Shares Gemtuzumab ozogamicin, Antibody-drug conjugate (ADC).
Shares Cytarabine + anthracycline ('7+3'), Acute myeloid leukaemia.
Shares Gemtuzumab ozogamicin, Antibody-drug conjugate (ADC).