Table 2.
Recent pivotal clinical trials for relapsed/refractory DLBCL
| Regimen (Trial name) | Trial design, n | Key inclusion criteria | Major efficacy endpoints |
|---|---|---|---|
|
Axicabtagene ciloleucel |
Phase II 111 |
Refractory DLBCL—defined as progressive or stable disease as the best response to the most recent chemotherapy regimen or disease progression or relapse within 12 months after ASCT |
ORR 82% (CR 49%) Median OS 25.8 months Median PFS 5.9 months |
|
Tisagenlecleucel |
Phase II 115 |
Relapsed or refractory DLBCL who were ineligible for or had disease progression after ASCT |
ORR 53% (CR 39%) Median OS 11.1 months Median PFS 2.9 months |
|
Lisocabtagene maraleucel (TRANSCEND NHL 001) [123] |
Phase II 269 |
Relapsed or refractory DLBCL after ≥ 2 lines of therapy |
ORR 73% (CR 53%) Median OS 21.1 months Median PFS 6.8 months |
|
Axicabtagene ciloleucel |
Phase III 359 |
Refractory to or relapsed ≤ 12 months after first-line treatment |
ORR 83% (CR 65%) Median OS not reached Median PFS 14.7 months |
|
Lisocabtagene maraleucel (TRANSFORM) [125] |
Phase III 184 |
Refractory to or relapsed ≤ 12 months after first-line treatment |
ORR 86% (CR 66%) Median OS not reached Median PFS 14.8 months |
| Polatuzumab vedotin, bendamustine, rituximab [126, 127] |
Phase II 80 |
Relapsed or refractory DLBCL after ≥ 1 line of therapy and were transplant-ineligible |
ORR 52.5% (CR 40%) Median OS 12.4 months Median PFS 9.5 months |
|
Tafasitamab, lenalidomide (L-MIND) [128] |
Phase II 80 |
Relapsed or refractory DLBCL after ≥ 1 line of therapy and were transplant-ineligible |
ORR 60% (CR 43%) Median OS not reached Median PFS 12.1 months |
|
Loncastuximab tesirine (LOTIS-2) [129] |
Phase II 145 |
Relapsed or refractory DLBCL after ≥ 2 lines of therapy |
ORR 48% (CR 24%) Median OS 9.9 months Median PFS 4.9 months |
|
Selinexor (SADAL) [130] |
Phase II 127 |
Relapsed or refractory DLBCL after ≥ 2 lines of therapy and progressed after or were transplant-ineligible |
ORR 28% (CR 12%) Median OS 9.1 months Median PFS 2.6 months |
ORR objective response rate, CR complete response, PR partial response, OS overall survival, PFS progression-free survival, DOR duration of response, ASCT autologous stem cell transplantation