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Intention to treat with chimeric antigen receptor (CAR) T-cell therapy relies on disease management during the manufacturing period of CAR T-cells. Bridging therapy (BT) is administered during this time to control the disease and ensure CAR T-cell infusion can be achieved. The Lymphoma Hub previously reported on the impact of BT on patient outcomes; below, we provide an update on the clinical data guidance.
Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are approved CAR T-cell therapies for the treatment of patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Previously, the Lymphoma Hub covered key considerations for preparing patients with B-cell non-Hodgkin lymphoma and acute lymphoblastic leukemia for CAR T-cell therapy. Here, we report on considerations for patients with LBCL.
This retrospective analysis reported data collected from adult patients with R/R LBCL from the United Kingdom National CAR Clinical Panel who underwent leukapheresis for axi-cel or tisa-cel. BT was defined as lymphoma-directed therapy administered between leukapheresis and lymphodepletion (Figure 1). Objectives were complete response and proceeding to CAR T-cell infusion, and comparison of safety and efficacy outcomes (overall response rates, progression-free survival, and overall survival) between patient groups treated with axi-cel and tisa-cel.
Overall, 375 patients with R/R LBCL underwent leukapheresis for CD19 CAR T-cell therapy, and 87% (326/375) received BT (Figure 1).
Figure 1. Patients disposition*
BT, bridging therapy; CAR T, chimeric antigen receptor T; CMT, combined modality therapy; RBP, rituximab-bendamustine-polatuzumab.
*Adapted by Roddie, et al.1
Baseline characteristics per bridging therapy group are summarized in Table 1.
Table 1. Baseline characteristics*
Characteristic, % (unless otherwise stated) |
No bridging (n = 49) |
Chemotherapy (n = 213) |
Radiotherapy (n = 62) |
Steroids (n = 35) |
Combined modality therapy (n = 16) |
---|---|---|---|---|---|
Age, years |
63 |
60 |
57 |
58 |
63 |
Male |
61.2 |
60.0 |
59.7 |
62.9 |
50 |
Female |
38.8 |
37.1 |
40.3 |
40 |
50 |
Disease type |
|||||
De novo LBCL |
63.3 |
69.5 |
64.5 |
68.6 |
56.3 |
PMBL |
6.1 |
5.2 |
6.5 |
0 |
12.5 |
tFL |
24.5 |
18.3 |
25.8 |
28.6 |
25.0 |
t-Other |
6.1 |
7.0 |
3.2 |
2.9 |
6.3 |
ECOG Performance Status |
|||||
1 |
63.3 |
37.6 |
51.6 |
51.4 |
18.8 |
2 |
36.7 |
62.4 |
48.4 |
48.6 |
81.3 |
Stage |
|||||
Stage 1–2 |
30.4 |
15.6 |
29.5 |
25.7 |
13.3 |
Stage 3–4 |
69.6 |
84.4 |
70.5 |
74.3 |
86.7 |
ECOG, Eastern Cooperative Oncology Group; LBCL, Large B-cell lymphoma; PMBL, primary mediastinal large B-cell lymphoma; tFL, transformed follicular lymphoma. |
|
Figure 2. Overall response rates in patients according to BT*
BT, bridging therapy; CMT, combined modality therapy; HDT, high-dose chemotherapy; LDT, low-dose chemotherapy; RBP, rituximab-bendamustine-polatuzumab; RT, radiotherapy.
Adapted from Roddie, et al.
Figure 3. Objective response rate to CAR T-cell therapy with or without BT*
CAR T, chimeric antigen receptor T-cell; CMT, combined modality therapy; RT, radiotherapy.
Adapted from Roddie, et al.
The multivariate analysis demonstrated that factors independently associated with a higher probability of response to bridging therapy were:
This study demonstrates the use of BT as a safe and effective strategy to improve CAR T-cell infusion, regardless of the type of BT used. No new safety signals were reported. This study suggests that BT in LBCL should be carefully planned toward optimal response and disease debulking, to improve patient outcomes. Eligible patients should consider receiving a regimen containing polatuzumab and where possible, additional lines of BT should be considered if BT fails to produce a complete or partial response before tisa-cel administration.
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