Table 2.
IRC- and investigator-assessed responses at EOI (efficacy-evaluable population; N = 40)
| Modified Lugano 2014 criteria (PET-CT) |
Lugano 2014 criteria (PET) |
Modified Cheson 2007 criteria (CT or MRI and PET) |
||||
|---|---|---|---|---|---|---|
| IRC | Investigator | IRC | Investigator | IRC | Investigator | |
| ORR, n (%) | 35 (87.5) | 35 (87.5) | 35 (87.5) | 35 (87.5) | 36 (90.0) | 35 (87.5) |
| CR | 31 (77.5) | 30 (75.0) | 32 (80.0) | 31 (77.5) | 31 (77.5) | 30 (75.0) |
| PR | 4 (10.0)∗ | 5 (12.5)∗,† | 3 (7.5) | 4 (10.0) | 5 (12.5)∗ | 5 (12.5)∗ |
| SD, n (%) | — | — | — | — | 1 (2.5) | — |
| PD, n (%) | 2 (5.0) | 2 (5.0) | 2 (5.0) | 2 (5.0) | 2 (5.0) | 2 (5.0) |
| NE, n (%)‡ | 3 (7.5) | 3 (7.5) | 3 (7.5) | 3 (7.5) | 1 (2.5) | 3 (7.5) |
MRI, magnetic resonance imaging; NE, nonevaluable; SD, stable disease.
∗
One patient response was downgraded from CR to PR because of missing bone marrow biopsy.
†
One patient had a PR at EOI by investigator, confirmed CR with biopsy after patient started consolidation. This patient was evaluated as CR by IRC at EOI.
‡
Two patients from the same site were missing EOI PET, 1 patient had PD by CT, and 1 patient discontinued treatment after cycle 3 because of AEs, in PR by CT. One patient withdrew consent before EOI assessment.