Info
cpx-351
CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin that delivers a synergistic 5:1 drug ratio into leukemia cells to a greater extent than normal bone marrow cells.
CPX-351 versus 7+3 for Newly Diagnosed Secondary Acute Myeloid Leukemia: A Phase III Randomized Clinical Trial
- Design: Phase III, open-label, randomized clinical trial
- Number of patients: 309 patients age 60 to 75 years
- Patients characteristics: Newly diagnosed high-risk/secondary acute myeloid leukemia (sAML)
- Agent: CPX-351 or 7+3
- Treatment line: One to two induction cycles of CPX-351 or 7+3 followed by consolidation therapy with a similar regimen
- Trial Name/NCT Number: Not reported
Comparison of CPX-351 vs. 7+3
| Endpoints | CPX-351 | 7+3 |
|---|---|---|
| OS | Median 9.56 months | Median 5.95 months |
| Response rate | Overall remission rate was 47.7% | Overall remission rate was 33.3% |
| Non-hematologic AEs | Comparable between arms | Comparable between arms |
- Other findings:
- Early mortality rates with CPX-351 and 7+3 were 5.9% and 10.6% (two-sided P = .149) through day 30 and 13.7% and 21.2% (two-sided P = .097) through day 60.
Summary
- CPX-351 significantly improved overall survival and response rate compared to 7+3 in older adults with newly diagnosed secondary acute myeloid leukemia (sAML).
- The safety profile of CPX-351 was similar to that of conventional 7+3 therapy, despite a longer treatment phase and prolonged time to neutrophil and platelet count recovery with CPX-351.
- Early mortality rates were lower with CPX-351 compared to 7+3, although the difference was not statistically significant.