ASCO 2016. 7000. Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML
Jeffrey E. Lancet et al.
Results: A total of 309 patients were randomized (153 to CPX-351 + 156 to 7+3) and were well balanced for sex, race, age, performance status, AML-subtype, MDS-related cytogenetics and prior HMA therapy. After minimum follow-up of 13.7 months final analysis began.CPX-351 treatment resulted in superior overall survival (HR=0.69; P=0.005; median OS 9.56 vs. 5.95 months), EFS (HR=0.74; P=0.021), and CR+CRi response (47.7% vs. 33.3%; P=0.016). 60-day mortality favored CPX-351 (13.7% vs. 21.2%). Grade 3-5 AEs were equal (92% vs. 91%) and were similar in frequency and severity in both arms. Similar numbers of patients were transplanted in both arms.
Conclusion: CPX-351 treatment significantly improved overall survival, event free survival, and response without an increase in 60-day mortality or AE frequency or severity. CPX-351 should become the standard of care for older patients with secondary AML. Clinical trial information: NCT01696084
CARE Faculty Perspective: Older patients do not experience very good outcomes with first-line 7+3 and thus new therapy options are required. This study looked at CPX-351, a therapy designed to provide fixed ratios of doxorubicin and cytarabine via an IV liposomal delivery system, in older patients with high risk secondary AML. Results from this trial showed a superior OS of approximately 4 months for CPX-351 when compared with 7+3 treatment regimen (cytarabine & daunorubicin). While the toxicity was similar, improved response rates, post-transplant outcomes, PFS and OS highlight the activity and safety of CPX-351. The study highlighted poor outcomes with standard therapy in this setting and CPX-351 is now a treatment showing survival advantages for these high risk patients.