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Table 2 Reports of CD19 CAR‐T cell therapy as second-line or first-line therapy for large B-cell lymphoma at the 2021 ASH annual meeting

From: Novel cellular immunotherapies for hematological malignancies: recent updates from the 2021 ASH annual meeting

Clinical trials (reference)

ZUMA-7 (axi-cel) [35]

TRANSFORM (liso-cel) [37]

BELINDA (Tisa-cel) [38]

ZUMA-12 (axi-cel) [39]

Study type

Phase 3, randomized, global

CAR-T VS SOC

Phase 3, randomized, global

CAR-T VS SOC

Phase 3, randomized, global

CAR-T VS SOC

Phase 2, multicenter, single-arm

Indication

Second-line

Second-line

Second-line

First-line

Patients (n)

359

184

322

40

Age (median, years)

59 (21–81)

59 (20–75)

50% patients ≥ 65 years

61 (23–86)

Inclusion criteria

 Aged ≥ 18 years with LBCL, ECOG PS 0–1, failure of first-line chemotherapy

Aged ≤ 75 years, eligible for ASCT, and with R/R LBCL within 12 months after first-line chemotherapy; ECOG PS ≤ 1 and adequate organ function

R/R NHL within 12 months after first-line chemotherapy

High-risk LBCL, defined by histology (double‑ or triple-hit status) or an IPI score ≥ 3, plus a positive interim PET after 2 cycles of chemotherapy

Bridging therapy permitted

No

No

Yes

NA

Response rate

(ORR/CR)

ORR: 83% vs 50%

CR: 65% vs 32%

ORR: 89% vs 48%

CR: 66% vs 39%

ORR: 46% vs 43%

CR: 28% vs 28%

ORR: 89%

CR: 78%

OS

Not reached vs 35.1 months

NA

NA

12-month estimate: 91%

PFS

8.3 months vs 2 months

14.8 months vs 5.7 months

3 months vs 3 months

Not reached

12-month estimate: 73%

Grade ≥ 3 neutropenia

NA

82%

NA

68%

Grade ≥ 3 thrombocytopenia

NA

58%

NA

NA

Grade ≥ 3 CRS

6%

1.1%

5%

8%

Grade ≥ 3 ICANS

21%

0

3%

23%

Follow-up (months)

24.9

6.2

10

15.9

  1. NA not applicable