Table 3.
Characteristic | Relapsed FL(n = 42)* |
Relapsed DLBCL(n = 47)† |
Refractory NHL(n = 30)‡ |
Total(N = 119) |
||||
---|---|---|---|---|---|---|---|---|
No. | % | No. | % | No. | % | No. | % | |
Age, years | ||||||||
Median | 64 | 72 | 63 | 65 | ||||
Range | 29-82 | 33-85 | 20-79 | 20-85 | ||||
> 60 | 26 | 62 | 32 | 68 | 16 | 53 | 74 | 62 |
Sex | ||||||||
Female | 20 | 48 | 19 | 40 | 9 | 30 | 48 | 40 |
Male | 22 | 52 | 28 | 60 | 21 | 70 | 71 | 60 |
Baseline ECOG performance status§ | ||||||||
0 | 26 | 62 | 23 | 49 | 13 | 43 | 62 | 54 |
1 | 15 | 36 | 15 | 32 | 13 | 43 | 43 | 38 |
2 | 0 | 6 | 13 | 3 | 10 | 9 | 8 | |
Baseline FLIPI/IPI score§ | ||||||||
0 | 3 | 7 | 2 | 4 | 1 | 3 | ||
1 | 7 | 17 | 8 | 17 | 4 | 13 | ||
2 | 15 | 36 | 19 | 40 | 7 | 23 | ||
3 | 7 | 17 | 13 | 28 | 9 | 30 | ||
4 | 9 | 21 | 3 | 6 | 4 | 13 | ||
5 | 1 | 2 | 0 | 1 | 3 | |||
Disease stage III to IV | 33 | 79 | 32 | 68 | 23 | 77 | 88 | 74 |
Bulky disease, cm | ||||||||
> 7.5 | 7 | 17 | 7 | 15 | 9 | 30 | 23 | 19 |
> 5.0 | 17 | 41 | 16 | 34 | 20 | 67 | 53 | 45 |
Increased LDH§ | 13 | 31 | 16 | 35 | 18 | 62 | 47 | 40 |
Bone marrow involvement§ | 13 | 31 | 8 | 17 | 6 | 20 | 27 | 23 |
Prior rituximab exposure | 42 | 100 | 47 | 100 | 30 | 100 | 119 | 100 |
No. of prior regimens | ||||||||
1 | 20 | 48 | 19 | 40 | 2 | 7 | 41 | 35 |
2 | 20 | 48 | 24 | 51 | 9 | 30 | 53 | 45 |
≥ 3 | 2 | 5 | 4 | 9 | 19 | 63¶ | 25 | 21 |
Prior radiotherapy | 6 | 14 | 14 | 30 | 12 | 40 | 32 | 27 |
Prior stem-cell transplantation | 2 | 5 | 9 | 19 | 3 | 10 | 14 | 12 |
Response to most recent prior therapy | ||||||||
Complete response | 24 | 57 | 30 | 64 | 1 | 3 | 55 | 46 |
Partial response | 13 | 31 | 14 | 30 | 1 | 3 | 28 | 24 |
Stable disease | 2 | 5 | 2 | 4 | 4 | 13 | 8 | 7 |
Disease progression | 3 | 7 | 1 | 2 | 24 | 80 | 28 | 24 |
Abbreviations: DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; IPI, International Prognostic Index; LDH, lactate dehydrogenase; NHL, non-Hodgkin lymphoma.
Includes one patient who received 0.8 mg/m2 inotuzumab ozogamicin and two patients who received 1.3 mg/m2 inotuzumab ozogamicin during dose-escalation phase (part 1).
Includes four patients who received 0.8 mg/m2 inotuzumab ozogamicin and one patient who received 1.3 mg/m2 inotuzumab ozogamicin during dose-escalation phase (part 1).
Consists of patients with DLBCL (n = 20), transformed FL (n = 5), and mantle cell lymphoma (n = 5).
Missing ECOG data (FL, n = 1; DLBCL, n = 3; refractory groups, n = 1), FLIPI/IPI data (DLBCL, n = 2; refractory groups, n = 4), LDH data (DLBCL, n = 1; refractory groups, n = 1), and bone marrow involvement data (FL, n = 2; DLBCL, n = 1; refractory groups, n = 1).
Includes nine patients with three prior therapies, seven patients with four prior therapies, and two patients with six prior therapies; one patient with Richter's transformation received nine prior therapies.