CPX-351 Study 301
Repackaging two old chemotherapies into liposomes doubled five-year survival in older adults with the worst kinds of AML.
Median OS 9.56 vs 5.95 months (HR 0.69, 95% CI 0.52-0.90, p=0.003); CR+CRi 47.7% vs 33.3%; 5-year OS 18% vs 8%; more patients reached transplant and post-transplant survival was longer. JCO 2018, Lancet Haematology 2021.
Setting
Newly diagnosed high-risk or secondary AML, age 60-75: CPX-351 vs conventional 7+3
Phase
Phase 3
Sponsor
Celator / Jazz
Registry
Headline result
OS 9.56 vs 5.95 months, HR 0.69; 5-year OS 18% vs 8%.
Reported
2018
Enrolled
309
Replication
No second randomised trial; UK NCRI AML19 and real-world registries report comparable remission rates in secondary AML.
In plain words
What these results mean for people, not percentages
Overall survival (median)primarysurvival endpoint
- Median 9.6 vs 6 months with CPX-351 compared with 7+3; about 3.6 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 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.52 to 0.9).
5-year overall survivalsurvival endpoint
- 18 vs 8 out of 100 alive at 5 years with CPX-351 compared with 7+3; 10 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Be careful
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Newly diagnosed high-risk or secondary AML, age 60-75: CPX-351 vs conventional 7+3. 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.
309 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | CPX-351 | 153 | 9.56 months | 0.69 (0.52–0.9) | 0.003 | link |
| 7+3 | 156 | 5.95 months | ||||
| 5-year overall survival | CPX-351 | — | 18% | — | — | link |
| 7+3 | — | 8% |
Replication
No second randomised trial; UK NCRI AML19 and real-world registries report comparable remission rates in secondary AML.