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Patients with refractory large B-cell lymphoma have a poor prognosis, with studies suggesting a median overall survival of just 6.3 months.1 Chimeric antigen receptor (CAR) T-cell therapies that target CD19 are a potential option in the treatment of these refractory large B-cell lymphomas. The Lymphoma Hub has previously reported on the ZUMA-1 study (NCT02348216), having seen preliminary data presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, CH, (our report can be found here) and at the American Association for Cancer Research (AACR) Annual Meeting 2017, Washington DC, US, (read the Lymphoma Hub article here). In their recent Lancet Oncology publication, Frederick Locke, H. Lee Moffitt Cancer Center & Research Institute, Tampa, US, and team reported on the 2-year activity and safety results of this phase 1–2, single-arm, multicentre study.
At the 12-month analysis, there were four AE-related deaths, including two that were attributable to axicel. There have been no new axicel-related deaths since then
Table 1. Baseline characteristics of included patients1
Data are presented as n (%) unless otherwise stated. IQR, interquartile range; ECOG PS, Eastern Cooperative Oncology Group performance status |
||
|
Phase I (n = 7) |
Phase II (n = 101) |
Median age, years (IQR) |
59 (34–69) |
58 (51–64) |
Sex Female Male |
2 (29%) 5 (71%) |
33 (33%) 68 (67%) |
ECOG PS 0 1 |
4 (57%) 3 (43%) |
42 (42%) 59 (58%) |
Disease stage I or II III or IV |
3 (43%) 4 (57%) |
15 (15%) 86 (85%) |
Neutropenia Any grade Grade ≥ 3 |
2 (29%) 1 (14%) |
16 (16%) 3 (3%) |
Thrombocytopenia Any grade Grade ≥ 3 |
3 (43%) 0 |
34 (34%) 4 (4%) |
Anemia Any grade Grade ≥ 3 |
5 (71%) 1 (14%) |
95 (94%) 2 (2%) |
Previous therapies Median (IQR) 1 2 ≥ 3 |
3 (3–4) 0 1 (14%) 6 (86%) |
3 (2–4) 3 (3%) 28 (28%) 70 (69%) |
History of primary refractory disease |
1 (14%) |
26 (26%) |
History of resistance to two consecutive lines |
1 (14%) |
54 (53%) |
Table 2. The most common treatment-emergent AEs of any grade (≥ 40%)1
Data are presented as n (%). *Includes five patients who had progression of their disease; this was recorded as AE AE, adverse event |
||||||
|
|
Worst grade |
||||
|
Any grade |
1 |
2 |
3 |
4 |
5 |
Any |
108 (100%) |
0 |
2 (2%) |
28 (26%) |
69 (64%) |
9 (8%)* |
Pyrexia |
94 (87%) |
17 (16%) |
62 (57%) |
15 (14%) |
0 |
0 |
Anemia |
73 (68%) |
4 (4%) |
20 (19%) |
46 (43%) |
3 (3%) |
0 |
Hypotension |
63 (58%) |
19 (18%) |
29 (27%) |
14 (13%) |
1 (1%) |
0 |
Nausea |
63 (58%) |
42 (39%) |
21 (19%) |
0 |
0 |
0 |
Fatigue |
57 (53%) |
32 (30%) |
22 (20%) |
3 (3%) |
0 |
0 |
Decreased appetite |
55 (51%) |
37 (34%) |
16 (15%) |
2 (2%) |
0 |
0 |
Headache |
50 (46%) |
40 (37%) |
9 (8%) |
1 (1%) |
0 |
0 |
Diarrhea |
48 (44%) |
33 (31%) |
10 (9%) |
5 (5%) |
0 |
0 |
Neutropenia |
48 (44%) |
1 (1%) |
5 (5%) |
10 (9%) |
32 (30%) |
0 |
Hypoalbuminemia |
43 (40%) |
17 (16%) |
25 (23%) |
1 (1%) |
0 |
0 |
Hypocalcemia |
43 (40%) |
20 (19%) |
16 (15%) |
7 (6%) |
0 |
0 |
Tachycardia |
43 (40%) |
38 (35%) |
3 (3%) |
2 (2%) |
0 |
0 |
Frederick Locke and team conclude that this represents the longest follow-up of an anti-CD19 CAR T-cell therapy study. The results demonstrate that a substantial proportion of patients with refractory large B-cell lymphoma treated with axicel achieve durable responses with manageable long-term safety.
In terms of limitations of the study, the team discuss the need for further studies to assess axicel in other large B-cell lymphoma settings, the effect on quality of life, the effect of prolonged cytopenias, and mechanisms of relapse, as these were not included in ZUMA-1.
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