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Table 1 Clinical trials of inotuzumab ozogamicin (INO)

From: Inotuzumab ozogamicin in clinical development for acute lymphoblastic leukemia and non-Hodgkin lymphoma

Reference Phase Disease Intervention INO + ORR (CR) mPFS mOS Significant toxicities
[55] 2 R/R Ph-Negative CD22 positive ALL Mini-Hyper-CVD with INO and Rituximab ORR was 78% (59% CR) MRD negative rates of 52% (at time of morphological response) and 82% (at 3 months). Median RFS of 8 months. 11 months VOD (15%); prolonged thrombocytopenia (81%); 95% suffered hepatotoxicity (20% with grade 3 or higher)
[63] 3 Refractory or Relapsed ALL 0.8 mg/m2 (D1), 0.5 mg/m2 (D8), 0.5 mg/m2 (D15) Versus Standard therapy CR + CRi 80.7% (CR 35.8%) 5 months 7.7 months Grade 3 or more thrombocytopenia, hepatotoxicity and VOD (11%)
[78] 1/2 R/R ALL 1.8 mg/m2 weekly 69% CR/CRi (29% CR)    cytopenias and liver toxicity
[84] 1 R/R FL (100%) Single agent 1.3 mg/m2 q28d with dose escalation up to MTD 1.8 mg/m2 q28d CR: 54% ORR: 85% No DLTs. MTD of 1.8 mg/m2 confirmed in Japanese population.
[85] 1/2 CD20 and CD22 positive B-NHL. Relapsed follicular lymphoma (35%), Relapsed diffuse large B-cell lymphoma (39%), or refractory aggressive NHL (25%) Dose escalation (0.8, 1.3 and 1.8 mg/m2) study in combination with Rituximab 375 mg/m2 MTD of determined to be 1.8 mg/m2. FL: 87% (62%) DLBCL: 74% (50%) Refractory: 20% FL: NR (2 year PFS rate of 68%) DLBCL: 17.1 months Refractory: 1.9 months. FL: 2 year OS rate 90% DLBCL: 3 year OS rate 69% Refractory: 8.8 months Grade 3 to 4 thrombocytopenia (31%) and neutropenia (22%). SAEs of Pneumonia (4%), Sepsis (3%) and liver dysfunction (4%). No VOD.
[86] 1 B-NHL (CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies) 1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles + R 375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles 80% (60%) NR NR 90% SAEs, with thrombocytopenia, neutropenia, elevated liver enzymes and hypophosphatemia
[87] 1 CD22 positive NHL with at least 1 prior treatment INO (0.8 mg/m2) + RCVP 84% (24%) 14.4 months 24.5 months 1 death due to neutropenic pneumonia in INO-CVP arm. (13/48) 27% discontinued therapy in INO-CVP arm due to adverse effects
[88] 1/2 CD22 positive NHL with at least 1 prior treatment; DLBCL (38%) FL (25%) MCL (24%) Refractory (42%) INO (0.8 mg/m2) + R- GDP Phase 1: 53% (20%); 6 m: 58% 12 m: 37% 24 m: 24% 6 m:81% 12 m: 61% 24 m: 55% Grade 3 or more thrombocytopenia (75%); neutropenia (62%). One patient with grade 3 VOD.
Phase 2 dose (RP2D): 50% (14%)
Refractory: 35%
  1. Abbreviations: R/R refractory /relapsed, CVD cyclophosphamide vincristine dexamethasone, m month, ORR overall response rate, CR complete remission, PFS progression free survival, OS overall survival, RFS relapse free survival, VOD veno-occlusive disease, NHL non-Hodgkin lymphoma, NR not reached, MRD minimal residual disease, MTD maximal tolerated dose, SAE serious adverse event, DLBCL diffuse large B cell lymphoma, FL follicular lymphoma, MCL mantle cell lymphoma, RP2D recommended phase 2 dose, GDP gemcitabine dexamethasone cisplatin