Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; 2 Sunesis Pharmaceuticals, Inc, South San Francisco
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1 Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients with Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) Naval Daver 1, Hagop Kantarjian 1, Guillermo Garcia-Manero 1, Naveen Pemmaraju 1, Tapan Kadia 1, Courtney DiNardo 1, Nitin Jain 1, Gautam Borthakur 1, Jorge Cortes 1, Adam Craig 2, and Farhad Ravandi 1 1 Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; 2 Sunesis Pharmaceuticals, Inc, South San Francisco
2 Vosaroxin: A First-in-Class Anticancer Quinolone Derivative (AQD) Key Characteristics Targeted topoisomerase II inhibitor Active in anthracyclineresistant settings Evades common drug resistance pathways (P-gp) Low potential for drug-drug interactions Limited distribution to normal tissues relative to anthracyclines Lower potential for off-target damage (cardiotoxicity) H 3 C Quinolone Core HN H 3 CO Vosaroxin O N N N S N CO 2 H Vosaroxin intercalates DNA and inhibits topoisomerase II, causing replicationdependent, site-selective DNA breaks, G2 arrest and cell death by apoptosis. Evanchi. Drug Metab Disp 2009; Hoch. Cancer Chemother Pharmacol 2009; Scaten. ibid 2010; Advani Clin Cancer Res 2010; Hawtin. PLoS One 2010; Hawtin. Oncotarget 2010; Haematologica 2011; Lancet Leukemia
3 Vosaroxin in AML Phase II study (REVEAL-1) of single-agent vosaroxin in newly diagnosed high-risk older AML patients age 60 years. CR/CRp Rate: 32% Median Overall Survival: 7.0 months 1-year Overall Survival: 34% 30-day All Cause Mortality: 12% Results from Phase III multinational VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory AML will be presented in a late-breaking presentation. Stuart RK, et al. Br J Haematol Nov 17. [Epub ahead of print] Ravandi F, et al. American Society of Hematology 2014 Annual Meeting. Late-breaker abstract #6. 3
4 Objectives Phase I (Lead-in) - Determine tolerability in patients with high-risk MDS (HR-MDS) or AML unsuitable for standard induction therapy Phase II - Primary: Overall response rate (CR + CRp + CRi) in patients with HR-MDS or AML unsuitable for standard induction therapy - Secondary: Determine overall survival and CR duration 4
5 Inclusion Criteria Untreated AML ( 20% blasts) HR-MDS or HR-CMML ( 10% blasts) Therapy for prior MDS before progression to AML acceptable Age 60 years and unsuitable for standard induction chemotherapy*; younger unsuitable patients also eligible Adequate hepatic (total bilirubin 1.5 x ULN) and renal function (creatinine 2.0 mg/dl) No uncontrolled infection *Kantarjian H, et al. Cancer Mar 1;106(5):
6 Design Induction Reinduction (if needed) C1 C2 C3 C4 C5 Maintenance Decitabine Vosaroxin mg/m 2 on days 1 and 4 Decitabine 20 mg/m 2 IV daily x 5 days Maximum up to 7 cycles on protocol Cycles repeated every 4-6 weeks depending on count recovery and toxicity 6
7 Results Phase I 6 patients received vosaroxin 90 mg/m 2 D1 and 4 No dose-limiting toxicities Phase II 17 patients received vosaroxin 90 mg/m 2 D1 and 4 - Grade 3 mucositis in 8 patients Subsequent 14 patients received vosaroxin 70 mg/m 2 D1 and 4 7
8 Patients Characteristics (N=37) Characteristic Age* Diagnosis AML de novo Secondary AML HR MDS de novo N (%) / Median [range] 70 [41-78] 17 (46) 19 (51) 16 (43) 18 (49) 3 (8) Prior Therapy for AHD Hypomethylating agent Lenalidomide 3 (8) 2 (6) 1 (3) Bone marrow blast % 40 [10 97] WBC [x10 9 /L] 4.1 [ ] Platelets [x10 9 /L] 40 [7-333] *1 patient below age of 60 yrs was unsuitable for standard chemotherapy and was enrolled in study. AHD, antecedent hematological disorders. 8
9 Patients Characteristics (N=37) Characteristic N (%) Cytogenetics Diploid -5/-7/complex Miscellaneous Insufficient metaphase Molecular TP53 RAS (K/N) IDH2 TET2 IDH1 DNMT3A CEBPA EZH2 ASXL1 JAK2 FLT3 15 (41) 13 (35) 8 (21) 1(3) 10 (27) 9 (25) 7 (19) 6 (16) 5 (14) 5 (14) 5 (14) 4 (11) 3 (8) 3 (8) 1 (3) 9
10 Response (N=37) Response / Outcome N (%) CR 22 (59) CRp 5 (14) CRi 1 (3) ORR 28 (76) No Response 4 (11) Died within 8 weeks of initiation 5 (13) Died 4 weeks 0 Died 8 weeks 5 MRD (-) at response by multi-planar flow 20/28 (71) 10
11 Disposition (N=37) Median follow-up (months) 6.2 ( ) Median cycles to response 1 (1 4) Median cycles administered 2 (1-7) No. still on study 6 No. off study 31 Reasons off: Stem cell transplant 6 Completed therapy 5 Death < 8 weeks 5 Primary refractory 4 Relapse 6 Prolonged myelosuppression 3 Death in CR 2 11
12 Response by Baseline Characteristic Parameter Age* Cytogenetics Mutation status Category Diploid -5/-7/Complex Miscellaneous Insufficient metaphases IDH2 IDH1 TP53 RAS Overall Response N (%) 14/17 (82) 13/19 (68) 11/15 (73) 9/13 (69) 7/8 (88) 1/1 7/7 (100) 2/5 (40) 7/10 (70) 4/9 (44) *1 patient below age of 60 yrs was unsuitable for standard chemotherapy and was enrolled in study. 12
13 Response by Induction Dose Number of cycles to best response Induction dose Patients (N) Deaths within 8 weeks Responders 1 cycle 2 cycles 3 cycles 4 cycles 90 mg/m mg/m
14 Toxicities at Least Possibly Related to Study Tx (N=37) Toxicities G1 G2 G3 G4 Total (%) Bilirubin (5) Diarrhea 2 2 (5) Mucositis (78) Nausea/Vomiting (14) Fungal infections 3 3 (8) Major infections (pneumonia, sepsis) (49) Other infections (27) 14
15 Outcomes Overall Survival Remission Duration Survival Probability Total=37; Died = 18 Median: 8.3 Months Remission Duration Probability CR / CRp/ CRi Total = 28; Relapsed = 5 Median: NR Months Months 15
16 Outcome - Overall Survival by Age Survival Probability Age Total Died Median NR mo p = Months 16
17 Outcome - Overall Survival by Cytogenetics Survival Probability Cytogenetics Total Died Median Diploid mo 5/ 7 Complex mo Miscellaneous mo p = Months 17
18 Conclusions Vosaroxin plus decitabine produces a significant response rate in older patients with AML Associated with a low induction mortality Regimen is moderately intensive and should be avoided in the very elderly and infirm Further studies should compare this to traditional cytotoxic strategies 1 8
Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; 2 Sunesis Pharmaceuticals, Inc, South San Francisco
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