Response rates in response-evaluable patients before consolidation
| Variable . | BICR . | Investigator . |
|---|---|---|
| Induction | ||
| After 2 cycles nivolumab + BV induction | ||
| No. | 44 | 44 |
| ORR | 37 (84) | 38 (86) |
| CMR | 26 (59) | 25 (57) |
| PMR | 11 (25) | 13 (30) |
| NMR | 5 (11) | 2 (5) |
| PMD | 1 (2) | 0 |
| Not evaluable | 0 | 1 (2) |
| Not reported | 1 (2) | 3 (7) |
| After 4 cycles nivolumab + BV induction | ||
| No. | 44 | 44 |
| ORR | 36 (82) | 39 (89) |
| CMR | 26 (59) | 29 (66) |
| PMR | 10 (23) | 10 (23) |
| NMR | 3 (7) | 2 (5) |
| PMD | 1 (2) | 2 (5) |
| Not evaluable | 3 (7) | 0 |
| Not reported | 1 (2)∗ | 1 (2)∗ |
| Intensification | ||
| After 2 cycles BV + bendamustine intensification | ||
| No. | 11 | 11 |
| ORR | 11 (100) | 11 (100) |
| CMR | 9 (82) | 10 (91) |
| PMR | 2 (18) | 1 (9) |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| After 4 cycles BV + bendamustine intensification | ||
| No. | 3 | 2 |
| ORR | 3 (100) | 2 (100) |
| CMR | 2 (67) | 2 (100) |
| PMR | 1 (33) | 0 |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| Any time before consolidation | ||
| Any time before on-protocol consolidation (nivolumab + BV ± BV + bendamustine) | ||
| No. | 35 | 35 |
| ORR | 35 (100) | 35 (100) |
| CMR | 33 (94) | 32 (91) |
| PMR | 2 (6) | 3 (9) |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| Any time before off-protocol consolidation | ||
| No. | 9 | 9 |
| ORR | 7 (78) | 8 (89) |
| CMR | 5 (56) | 7 (78) |
| PMR | 2 (22) | 1 (11) |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| Not evaluable | 1 (11) | 0 |
| Not reported | 1 (11) | 1 (11) |
| Variable . | BICR . | Investigator . |
|---|---|---|
| Induction | ||
| After 2 cycles nivolumab + BV induction | ||
| No. | 44 | 44 |
| ORR | 37 (84) | 38 (86) |
| CMR | 26 (59) | 25 (57) |
| PMR | 11 (25) | 13 (30) |
| NMR | 5 (11) | 2 (5) |
| PMD | 1 (2) | 0 |
| Not evaluable | 0 | 1 (2) |
| Not reported | 1 (2) | 3 (7) |
| After 4 cycles nivolumab + BV induction | ||
| No. | 44 | 44 |
| ORR | 36 (82) | 39 (89) |
| CMR | 26 (59) | 29 (66) |
| PMR | 10 (23) | 10 (23) |
| NMR | 3 (7) | 2 (5) |
| PMD | 1 (2) | 2 (5) |
| Not evaluable | 3 (7) | 0 |
| Not reported | 1 (2)∗ | 1 (2)∗ |
| Intensification | ||
| After 2 cycles BV + bendamustine intensification | ||
| No. | 11 | 11 |
| ORR | 11 (100) | 11 (100) |
| CMR | 9 (82) | 10 (91) |
| PMR | 2 (18) | 1 (9) |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| After 4 cycles BV + bendamustine intensification | ||
| No. | 3 | 2 |
| ORR | 3 (100) | 2 (100) |
| CMR | 2 (67) | 2 (100) |
| PMR | 1 (33) | 0 |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| Any time before consolidation | ||
| Any time before on-protocol consolidation (nivolumab + BV ± BV + bendamustine) | ||
| No. | 35 | 35 |
| ORR | 35 (100) | 35 (100) |
| CMR | 33 (94) | 32 (91) |
| PMR | 2 (6) | 3 (9) |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| Any time before off-protocol consolidation | ||
| No. | 9 | 9 |
| ORR | 7 (78) | 8 (89) |
| CMR | 5 (56) | 7 (78) |
| PMR | 2 (22) | 1 (11) |
| NMR | 0 | 0 |
| PMD | 0 | 0 |
| Not evaluable | 1 (11) | 0 |
| Not reported | 1 (11) | 1 (11) |
Data are given as number (percentage) unless stated otherwise. CMR and PMR rates may not sum to ORR because of rounding. Patients who withdrew consent during the study or who proceeded to follow-up after induction were included for response assessment.
NMR, no metabolic response; PMD, progressive metabolic disease; PMR, partial metabolic response.
One patient discontinued because of study drug toxicity after 2 cycles of induction with nivolumab plus BV.