Table 5 Brexucel real-world studies in r/r MCL.
UK [82] | DESCAR-T [87] | SIE [83] | DRST/GLA/ SAKK [98] | US CART consortium [26] | |
|---|---|---|---|---|---|
Study type | Registry retrospective | Registry retrospective | Registry retrospective | Registry retrospective | Registry retrospective |
Eligibility | ≥2L incl. BTKi; PS 0-1; no CNS disease | EMA label | ≥2L; r/r to BTKi; ZUMA-2 eligible | EMA label | FDA label |
N | |||||
# intended | 119 | 178 | n.a. | n.a. | n.a. |
# apheresed (%) | 104 (87%) | n.a. | n.a. | n.a. | 189 |
# infused (%) | 83 (70%) | 152 (85%) | 106 | 111 | 168 (89%) |
Period | 2021–2023 | 2019–2023 | 2019–2024 | 2021–2023 | 2020–2021 |
Age (years; median (range)) | 68 (41–80) | 68 (39–83) | 63 (42–79) | 68 (50–84) | 67 (34–89) |
PS > 1 (ECOG) | 0 | 12% | 0 | 7% | 14% |
High-risk features | |||||
Ki-67 ≥ 30% | 78% | 79% | 54% | 79% | 78% |
Blastoid/pleomorph. | 42% | 31% | 30% | 33% | 40% |
TP53abn | 53% | 30% | 29% | 27% | 48% |
POD24 | 57% | n.a. | 42% | n.a. | 51% |
Prior lines/median (range) | 2 (2–7) | 3 (1–9) | 3 (2–5) | 3 (1–8) | 3 (1–10) |
Prior autoHCT | 34% | 40% | 58% | 55% | 28% |
Prior alloHCT | 13% | 6% | - | 8% | 3% |
BTKi refractory | 30% | n.a. | 35% | 58% | 76% |
Holding/Bridging | 90% | 83% | 79% | 74% | 68% |
CIT | 50% | n.a. | 31% | 35% | 34% |
BTKi ± CD20. | 17% | n.a. | 45% | 28% | 24% |
Venetoclax ± x | 10% | n.a. | 13% | 20% | 27% |
Response to Bridging | 41% (37/91) | 41% (51/125) | 18% (15/83) | 65% (42/65) | 33% (32/95) |
Toxicity | |||||
Neurotox ≥ G3 (any) | 22% (55%) | 15% (55%) | 18% (48%) | 28% (54%) | 32% (61%) |
Late ICAHT ≥ G2 | 59% | 9% (≥G3) | 4.4% (≥G3) | n.a. | >18% |
Severe infection | >30% | >25% | n.a. | 31% | >21% |
ICU admission | 27% | 34% | 18% | 22% | 20% |
T cell recovery 6mo | na | na | na | 23% | na |
Non-relapse mortality (12mo) | 18%d | 18%a | 7.3% | 10%a | 7.1% 10.7%d |
Best ORR/CR | 87%/81% | 85%/72% | 88%/75% | 88%/64% | 90%/82% |
PFS from infusion (12mo) | 62% | 46% | 62% | 69% | 69% |
OS from infusion (12mo) | 74% | 70%c | 82% | 74% | 82% |
Median follow-up (months) | 13 | 12 | 12 | 12 | 14 |
