Meeting
2020 ASCO Virtual Scientific Program
Five-year final results of a phase III study of CPX-351 versus 7+3 in older adults with newly diagnosed high-risk/secondary AML.
Authors
Jeffrey E. Lancet
H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL
Jeffrey E. Lancet , Geoffrey L. Uy , Laura F. Newell , Tara L. Lin , Ellen K. Ritchie , Robert K. Stuart , Stephen Anthony Strickland , Donna Hogge , Scott R. Solomon , Dale Bixby , Jonathan E. Kolitz , Gary J. Schiller , Matthew Joseph Wieduwilt , Daniel H. Ryan , Stefan Faderl , Yu-Lin Chang , Jorge Cortes
Organizations
H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, Washington University School of Medicine, St. Louis, MO, Oregon Health & Science University, Portland, OR, University of Kansas Medical Center, Kansas City, KS, Weill Cornell Medical College of Cornell University, New York, NY, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, Vanderbilt-Ingram Cancer Center, Nashville, TN, Leukemia/BMT Program of British Columbia, Vancouver, BC, Canada, Leukemia Program, Northside Hospital Cancer Center Institute, Atlanta, GA, Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, Monter Cancer Center, Northwell Health System, Lake Success, NY, David Geffen School of Medicine at UCLA, Los Angeles, CA, University of California–San Diego Moores Cancer Center, La Jolla, CA, University of Rochester, Rochester, NY, Jazz Pharmaceuticals, Palo Alto, CA, The University of Texas MD Anderson Cancer Center, Houston, TX and Georgia Cancer Center, Augusta University, Augusta, GA
Research Funding
Pharmaceutical/Biotech Company
Jazz Pharmaceuticals
Background: CPX-351 (Vyxeos; daunorubicin and cytarabine liposome for injection), a dual-drug liposomal encapsulation of cytarabine [C] and daunorubicin [D], is approved by the FDA and EMA for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. Primary analysis of the pivotal phase 3 study (NCT01696084) that formed the basis for these approvals evaluated patients (pts) aged 60-75 y with newly diagnosed high-risk/secondary AML and found that CPX-351 significantly improved median overall survival (OS) vs conventional 7+3, with a comparable safety profile. Here, we report the prospectively planned final 5-y follow-up results from this phase 3 study. 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 complete remission (CR) or CR with incomplete platelet or neutrophil recovery could receive up to 2 consolidation cycles. Pts could receive a hematopoietic cell transplant (HCT) at the physician’s discretion. Pts were followed until death or up to 5 y following randomization. Results: In total, 309 pts were randomized to CPX-351 (n = 153) or 7+3 (n = 156). The survival rate at 5 y was higher for CPX-351 vs 7+3 (18% vs 8%; Table). Among pts who died, the most common primary cause of death was progressive leukemia in both arms (CPX-351: 56%; 7+3: 53%). After a median follow-up of 60.65 mo, improved median OS with CPX-351 vs 7+3 was maintained: 9.33 vs 5.95 mo; Kaplan-Meier (KM) OS curves plateaued at ~30 mo. HCT was received by 53 (35%) vs 39 (25%) pts after CPX-351 vs 7+3; among these pts, the survival rate at 5 y was higher for CPX-351 vs 7+3 (52% vs 23%), and median OS landmarked from the HCT date was not reached for CPX-351 vs 10.25 mo for 7+3 (Table). Conclusions: After 5 y of follow-up, improved OS was maintained in this phase 3 study, supporting that CPX-351 has the ability to produce or contribute to long-term remission and survival in older pts with newly diagnosed high-risk/secondary AML. Clinical trial information: NCT01696084.
| CPX-351 (n = 153) | 7+3 (n = 156) | |
|---|---|---|
| Median follow-up (10th-90th percentiles),a mo | 60.91 (58.84-63.97) | 59.89 (58.22-63.90) |
| Median OS, mo HR (95% CI) | 9.33 0.70 (0.55-0.91) | 5.95 |
| 3-y survival rate,a % | 21 | 9 |
| 5-y survival rate,a % | 18 | 8 |
| HCT rate | 35 | 25 |
| Median OS landmarked from HCT date, mo HR (95% CI) | Not reached 0.51 (0.28-0.90) | 10.25 |
| 3-y survival rate in pts with HCT,a % | 56 | 23 |
| 5-y survival rate in pts with HCT,a % | 52 | 23 |
aKM estimated.
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Abstract Details
Session Type
Poster Discussion 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 7510)
DOI
10.1200/JCO.2020.38.15_suppl.7510
Abstract #
7510
Poster Bd #
283
Abstract Disclosures
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