Inotuzumab Ozogamicin in ALL. Hagop Kantarjian M.D. May 2016 Bologna, Italy
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1 Inotuzumab Ozogamicin in ALL Hagop Kantarjian M.D. May 2016 Bologna, Italy
2 Immuno Oncology in ALL Monoclonals + cytotoxic agents e.g.inotuzumab Bispecific monoclonals (CD3 + CD19) e.g.blinatumomab Modified expanded Tcells CART cells
3 Monoclonal Antibodies in ALL Bi-specific MoAb (CD19 & CD3) Jabbour E. Blood 125: 4010; 2015
4 Monoclonal Antibodies in ALL Rituximab established role in Burkitt and pre B CD20-positive ALL in combination with chemorx Inotuzumab anti-cd22 + calicheamicin Epratuzumab anti-cd22 Blinatumomab CD19 + CD3 Alemtuzumab anti-cd52 SAR3419 anti CD19 + mytansin SNG19A anti-cd19 + auristatin Anti-CD22 + auristatin 4
5 Inotuzumab ozogamicin Advani et al. JCO 2010
6 Inotuzumab in ALL: Schedule Monthly: Cycle 1 Cycle 2 up to 8 cycles 1.8mg/m 2 1.8mg/m 2 D1 D8 D15 D22 D29 D8 D15 D22 Weekly: Cycle 1 Cycle 2 up to 8 cycles 0.8mg/m 2 0.8mg/m 2 0.5mg/m 2 0.5mg/m 2 0.5mg/m 2 0.5mg/m 2 D1 D8 D15 D22 D29 D8 D15 D22 Kantarjian, Lancet Oncology 13: 403;2012, Kantarjian, Cancer. 119: ; 2013
7 Inotuzumab in ALL. Response Response No. (%) Monthly, N=49 Weekly, N=40 Overall, N=90 CR 9 (18) 8 (20) 17 (19) CRp 14 (29) 13 (32) 27 (30) CRi (marrow CR) 5 (10) 3 ( 7) 8 (9) Resistant 19 (39) 15 (37) 34 (38) Death < 4 wks 2 (4) 2 (5) 4 (4) OR 28 (57) 24 (59) 52 (58) Median CRD 5-6 mos;median survival mos Better results in S1-S2 Kantarjian, Cancer. 119: ; 2013
8 O Brien, Blood 120: abst 671;2012 Inotuzumab in ALL. Efficacy Comparison % Resp. to MDACC Data Base for CR/CRp Overall N=89 % ORR Inotuzumab Monthly N=49 Weekly N=40 Chemo n=292 P Overall <0.001 S S <0.001 S
9 Inotuzumab-Survival By Salvage Kantarjian. Cancer. (2013) 119:
10 Reference Inotuzumab Experience Rx MDACC mg/m 2 D1 MDACC 41 Advani 35 DeAngelo 218 total 109 Ino MDACC 24 Ino dose-schedule ALL Status Comment 0.8mg/m 2 D1 0.5mg/m 2 D8, mg/m 2 D1 0.5mg/m 2 D8, mg/m 2 D1 0.5mg/m 2 D8, mg/m 2 C1D3 1.3mg/m 2 D3 during Cycles 2-4 Relapsed, refractory Relapse, refractory Relapsed, refractor (Salvage 2 or greater) Relapsed, refractory (Salvage 1 or 2 only) Relapsed, refractory *Rituximab 375mg/m 2 CR/CRp/ CRi (%) Overall Response (%) 18/ 29/ Monotherapy 20/ 32/ 7 59 Monotherapy 31.4/ NR/ Monotherapy (COMPARED to SOC) 36/ NR/ Mini-hyperCVD-R 46/ 25/ 4 75 MDACC mg/m 2 C1D3 1.3mg/m 2 D3 during Cycles 2-4 New Dx Mini-hyperCVD-R 80/ 17/ NR Kantarjian l, Cancer. (2013) 119: Advani l abstract (ASH 2014) 3. DeAngelo Haematologica. (2015) 100:S1 abstract LB2073 (EHA 2015) 4. Jabbour. J Clin Oncol 32:5s, (2014) suppl; abstr 7019 (ASCO 2014) 5. Jabbour. Haematologica. (2015) 100:S1 abstract S114 (EHA 2015)
11 Inotuzumab Ozogamycin in ALL Salvage 2 35 pts Rx with ino 1.8 mg/m 2 ORR 24/35 = 69% - 10 CR + 14 CRi MRD negative in 18/24 = 75% Post Rx SCT 8/35 (23%) Median survival 6.4 mos VOD 3 (2 post allo SCT) Advani. Blood 124: abst ; 2014
12 Inotuzumab vs Chemo Rx in ALL Salvage Phase 3 study; 326 pts randomized; 117 sites in 19 countries (INO-VATE ALL; NCT ) Relapsed/refractory CD22+ ALL Due for salvage 1 or 2 therapy Ph or Ph+ 1:1 Randomization (N=326) Stratifications: Duration of 1st remission 12 vs <12 mo Salvage 2 vs 1 Aged 55 y vs <55 y Inotuzumab ozogamicin (InO) Starting dose 1.8 mg/m 2 /cycle 0.8 mg/m 2 on day 1; 0.5 mg/m 2 on days 8 and 15 of a day cycle ( 6 cycles) Standard of Care (SOC) FLAG or Ara-C plus mitoxantrone or HIDAC 4 cycles InO dose was reduced to 1.5 mg/m 2 /cycle once the patient achieved CR/CRi EHA 2015
13 Ino vs. Chemo Rx. Endpoints Primary endpoints Split-α design used for 2 primary endpoints (1-sided α=0.0125) 1. CR/CRi --Based on first 218 patients randomized 2. Overall survival (OS)-- assessed in all 326 randomized patients after 248 events Key secondary endpoints MRD-negativity in CR/CRi (<0.01% by FCM) Safety Duration of remission Progression-free survival Stem cell transplant (SCT) rate
14 Invo vs. Chemo Rx. Study Group Population InO SOC Total Definition ITT All randomized patients up to October 2, 2014 ITT The first 218 patients randomized Primary population for final CR/CRi analysis 13 patients randomized to SOC refused to start treatment All randomized patients Safety Enrollment 139 completed: who patients received --January 1 dose 4, 2015 Second interim analysis of OS (for futility and efficacy)-- February 20, 2015
15 Ino vs. Chemo Rx. Study Group Characteristic InO (n=109) SOC (n=109) Median (range) age, y 47 (18 78) 47 (18-79) Men, n (%) 61 (56) 73 (67) ECOG PS, n (%) 0 43 (39) 45 (41) 1 50 (46) 53 (49) 2 15 (14) 10 (9) Salvage, n (%) 1 73 (67) 69 (63) 2 35 (32) 39 (36) CRD1 at baseline, n (%) <12 months 62 (57) 71 (65) 12 month 47 (43) 38 (35) CR to most recent prior Rx, n (%) 78 (72) 74 (68)
16 Ino vs Chemo Rx. Study Group (2) Characteristic InO (n=109) SOC (n=109) Median WBC count 3.5 (0 47.4) 3.8 ( ) Median peripheral blasts 0.2 (0 42.7) 0.4 (0 31.5) No circulating peripheral blasts, n (%) 42 (39) 48 (44) CD22 expression on ALL blasts, n (%) <90% 24 (22) 24 (22) 90% 74 (68) 63 (58) Missing 11 (10) 22 (20) Karyotype, n (%) Normal 27 (25) 23 (21) Ph+ 14 (13) 18 (17) t(4;11) 3 (3) 6 (6) Other abnormalities 49 (45) 46 (42) Unknown/missing 16 (15) 16 (15)
17 Ino vs Chemo Rx in ALL Salvage. Response InO SOC N Sided P Value CR/CRi,% < CR CRi < MRD-negativity among responders CR/CRi, % < EHA. 2015
18 Ino vs. Chemo Rx. CR/CRi by Stratification Factors CR/CRi, % InO (n=109) SOC (n=96) 1-Sided P value In favor of InO CR/CRi Rate Difference (%) % Rate Difference (97.5% CI) All patients < (34 61) Duration of 1 st Remission <12 mo < (34 67) 12 mo (18 64) Salvage < (41 72) Salvage (2 56) Age < < (27 62) Age < (31 75)
19 Ino vs. Chemo Rx. CR/CRi by Baseline InO (n=109) CR/CRi a SOC (n=96) 1-Sided P Value Characteristic Peripheral blasts, n (%) /74 (82) 27/72 (38) < > /34 (77) 5/23 (22) < CD22 expression, b n (%) <90 19/24 (79) 6/22 (25) /74 (82) 23/58 (40) < Karyotype, n (%) Normal 19/20 (95) 6/16 (38) Ph+ 11/14 (79) 8/15 (53) t(4;11) 1/3 (33) 2/5 (40) Other abnormalities 42/49 (86) 12/42 (29) < Previous SCT, n (%) Factors Yes 13/17 (77) 6/19 (32) No 75/92 (82) 26/77 (34) <0.0001
20 Probability of Retaining Remission Ino vs Chemo Rx in ALL Salvage CRD Months Patients At Risk, n InO SOC EHA Median (95% CI) Duration of Remission InO (n=85) 4.6 ( ) mo SOC (n=31) 3.1 ( ) mo Hazard Ratio (95% CI) 0.55 ( ); 1-sided P=0.0169
21 Ino vs. Chemo Rx. Hepatotoxicity AEs Patients with all causality hepatobiliary TEAEs,n (%) InO (n=139) SOC (n=120) Hyperbilirubinemia 21 (15) 12 (10) VOD/SOS 15 (11) 1 (1) In the InO arm, 10 patients had VOD/SOS after poststudy SCT, while 5 had VOD/SOS during Rx (2 with and 3 without pre-study SCT) Median (range) time to VOD/SOS after SCT in the InO arm 16 (3 39) days Multivariate analysis-- dual alkylator conditioning (yes vs no) was the only significant covariate of VOD/SOS (P=0.039)
22 Rx of Elderly ALL Author/ Age No. CR rate OS Group/Study of pts (%) Kantarjian 2000 > % (at 5 yrs) MD Anderson Annino % (at 8 yrs) GIMEMA 0208 Larson 2005 > % (at 3 yrs) CALGB Sancho % (at 5 yrs) PETHEMA ALL96 Pullarkat % (at 5 yrs) SWOG 9400 Hunault-Berger % (at 2 yrs) GRAALL Gökbuget % (at 5 yrs) GMALL Sive % (at 8 yrs) UK NCRI
23 MiniHCVD-INO in ALL. Design Intensive phase D3 D3 D3 D3 Maintenance phase 36 months MiniHCVD Mini-MTX-cytarabine POMP Maintenance Inotuzumab Inotuzumab First 6 pts 7 to and beyond First cycle (mg/m 2 ) C2-4 (mg/m 2 )
24 Combination therapy Mini-hyper-CVD + Inotuzumab Dose reduced HyperCVD for 8 courses Cyclophosphamide 50% dose reduction Dexamethasone 50% dose reduction No anthracycline Methotrexate 75% dose reduction Cytarabine 0.5 g/m2 x 4 doses Inotuzumab on day 3 (first 4 courses) 1.8 mg/m2 course mg/m2 courses 2-4 Rituximab days 2 and 8 (first 4 courses) Intrathecal chemotherapy days 2 and 8 (first 4 courses) POMP maintenance for 3 years Jain. Blood 122: abst 1432; 2013
25 MiniHCVD-INO in ALL. Response (N=35) Response N (%) CR 28 28/35 (80) CRp 6 6/35 (17) ORR 34 34/35 (97) No response 1 1/35 (3) Early death 0 0 Three patients were enrolled with CR
26 MiniHCVD-INO in ALL. Outcome 2-yr CRD and OS rates 81% and 64%, respectively
27 MiniHCVD-INO vs HCVAD in ALL. Overall Survival
28 MiniHCVD-INO in R/R ALL. Response (N=52) Response N (%) CR CRp CRi 3 6 ORR MRD negativity at response 13/35 37 Overall 33/40 82 No response 5 10 Early death 7 14 Sasaki. Blood. 2015; 126: Abst # 3721
29 MiniHCVD-INO in R/R ALL. Survival 2-yr PFS and OS rates 60% and 32%, respectively Sasaki. Blood. 2015; 126: Abst # 3721
30 MiniHCVD-INO in R/R ALL. Survival Sasaki. Blood. 2015; 126: Abst # 3721
31 MiniHCVD-INO vs INO in R/R ALL. Survival Sasaki. Blood. 2015; 126: Abst # 3721
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