BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
3L Trial
Number of responders (n=141/192)1 | Median months (95% Cl) |
---|---|
DOR | 16.7 (5.3, NR),‡ range§: 0.0+ to 23.5+ |
DOR if best response is CR |
NR (16.7, NR),‡ range§: 0.7+ to 23.5+ |
DOR if best response is PR |
1.4 (1.1, 2.2),‡ range§: 0.0+ to 22.8+ |
CR | PR | TotalORR |
104 | 37 | 141 |
78 | 5 | 83 |
68 | 3 | 71 |
64 | 3 | 67 |
40 | 3 | 43 |
35 | 3 | 38 |
17 | 1 | 18 |
16 | 1 | 17 |
0 | 0 | 0 |
CR | PR | NR | Total |
136 | 51 | 70 | 257 |
135 | 46 | 42 | 223 |
128 | 34 | 28 | 190 |
120 | 25 | 17 | 162 |
116 | 16 | 14 | 146 |
112 | 12 | 12 | 136 |
109 | 10 | 130 | |
105 | 8 | 11 | 124 |
88 | 6 | 9 | 103 |
62 | 5 | 5 | 72 |
47 | 4 | 4 | 55 |
47 | 3 | 3 | 46 |
40 | 3 | 2 | 35 |
22 | 0 | 1 | 23 |
17 | 1 | 18 | |
12 | 1 | 13 | |
8 | 0 | 8 | |
3 | 3 | ||
0 | 0 |
Characteristics1,2 | (N=269) |
---|---|
Median age, years (range) | 63 (18-86) |
≥65 years/≥75 years | 42%/10% |
Large B-cell lymphoma subtype, n (%) | |
DLBCL, NOS | 53% |
DLBCL transformed from indolent lymphoma | 25% |
Double-/triple-hit B-cell lymphoma | 14% |
Primary mediastinal large B-cell lymphoma | 7% |
Follicular lymphoma, Grade 3B | 1% |
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