Meeting
2020 ASCO Virtual Scientific Program
Outcomes in older patients with high-risk/secondary AML who achieved remission with CPX-351 versus 7+3 but did not undergo transplant: Phase 3 exploratory analysis.
Authors
Tara L. Lin
University of Kansas Medical Center, Kansas City, KS
Tara L. Lin , Robert J Ryan , Stefan Faderl , Ellen K. Ritchie
Organizations
University of Kansas Medical Center, Kansas City, KS, Jazz Pharmaceuticals, Philadelphia, PA, Jazz Pharmaceuticals, Palo Alto, CA, Weill Cornell Medical College of Cornell University, New York, NY
Research Funding
Pharmaceutical/Biotech Company
Jazz Pharmaceuticals
Background: CPX-351 (Vyxeos; daunorubicin [D] and cytarabine [C] liposome for injection) is approved by the FDA and EMA for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. In a phase 3 study (NCT01696084) in patients (pts) aged 60-75 y with newly diagnosed high-risk/secondary AML, CPX-351 demonstrated significantly longer overall survival (OS) and higher rates of remission and hematopoietic cell transplant (HCT) vs conventional 7+3, with a comparable safety profile. To better understand the impact of treatment on outcomes in pts who did not undergo HCT, this exploratory analysis evaluated outcomes in the subgroup who achieved complete remission (CR) or CR with incomplete neutrophil or platelet recovery (CRi) with CPX-351 vs 7+3 but did not undergo HCT. Methods: Pts were randomized 1:1 to receive ≤2 induction cycles of CPX-351 (100 units/m2 [C 100 mg/m2 + D 44 mg/m2] as a 90-min infusion on Days 1, 3, 5 [2nd induction: Days 1, 3]) or 7+3 (C 100 mg/m2/d continuously for 7 d + D 60 mg/m2 on Days 1-3 [2nd induction: 5+2]). Pts achieving CR or CRi could receive up to 2 consolidation cycles. Pts could receive HCT at the physician’s discretion. Results: CR+CRi was achieved by 73/153 (48%) pts with CPX-351 vs 52/156 (33%) with 7+3; of these pts, 33/73 (45%) vs 28/52 (54%) did not subsequently undergo HCT. The baseline characteristics of these pts were generally balanced between arms; however, the CPX-351 arm had more male pts vs 7+3 (64% vs 43%) and pts with ECOG PS of 1 (82% vs 54%), and fewer pts with antecedent MDS and HMA exposure (21% vs 39%). Median OS was longer with CPX-351 vs 7+3 (14.72 vs 7.59 mo; HR = 0.57 [95% CI: 0.31-1.03]; Table). There was no early mortality by Day 60 in either arm (see Table for additional data). Conclusions: CPX-351 improved median OS vs 7+3 in pts who achieved CR+CRi but did not undergo HCT, suggesting a treatment benefit with CPX-351 even among pts who do not undergo HCT. The CPX-351 safety profile in this subgroup was consistent with the overall study population and known profile of 7+3. Clinical trial information: NCT01696084.
| CPX-351 (n = 33) | 7+3 (n = 28) | |
|---|---|---|
| Median OS in pts with CR+CRi, mo | 14.72 | 7.59 |
| HR (95% CI) | 0.57 (0.31-1.03) | |
| Median OS in pts with CR,a mo | 19.15 | 8.41 |
| Grade 3/4 AEs, n (%) | 31 (94) | 20 (71) |
| Serious AEs, n (%) | 25 (76) | 15 (54) |
| Febrile neutropenia | 5 (15) | 4 (14) |
| Acute respiratory failure | 4 (12) | 1 (4) |
| Pneumonia | 1 (3) | 3 (11) |
| Grade 5 AEs, n (%) | 2 (6) | 5 (18) |
| Median (range) days to recovery | ||
| Neutrophils ≥500/µL | 35 (21-63) | 29 (21-43) |
| Platelets ≥50,000/µL | 36 (14-106) | 28.5 (21-144) |
aCPX-351: n = 27; 7+3: n = 21.
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Abstract Details
Session Type
Poster Session
Session Title
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Track
Hematologic Malignancies
Sub Track
Acute Leukemia
Clinical Trial Registration Number
NCT01696084
Citation
J Clin Oncol 38: 2020 (suppl; abstr 7537)
DOI
10.1200/JCO.2020.38.15_suppl.7537
Abstract #
7537
Poster Bd #
310
Abstract Disclosures
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