ALFA-0701
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giving gemtuzumab in three small doses with chemotherapy improved event-free survival without the toxicity that got it withdrawn.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.
- Median 17.3 vs 9.5 months with GO + 7+3 compared with 7+3; about 7.8 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 44 percent lower chance of the event at any given time (hazard ratio 0.56, likely range 0.42 to 0.76).
- 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.
- Median 27.5 vs 21.8 months with GO + 7+3 compared with 7+3; about 5.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Not significant vs control.
- These results apply to the people the trial enrolled: Newly diagnosed de novo AML, age 50-70: fractionated gemtuzumab ozogamicin added to 7+3 vs 7+3 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.
271 participants enrolled.
Not significant vs control
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (median)primary | GO + 7+3 | 135 | 17.3 months | 0.56 (0.42–0.76) | — | link |
| 7+3 | 136 | 9.5 months | ||||
| Overall survival (median) | GO + 7+3 | — | 27.5 months | — | — | — |
| 7+3 | — | 21.8 months |
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not linked directly; found by shared links- TrialCPX-351 Study 301
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