Primary and key secondary efficacy outcomes (intention-to-treat population)
| Outcome . | Pola-R-CHP (n = 141) . | R-CHOP (n = 140) . |
|---|---|---|
| PFS, number of events (%)∗ | 30 (21.3) | 40 (28.6) |
| Death, n | 2 | 4 |
| Progression or relapse, n | 28 | 36 |
| HR (95% CI) | 0.64 (0.40-1.03) | |
| 2-y rate (95% CI) | 74.2 (65.7-82.7) | 66.5 (57.3-75.6) |
| EFS, number of events (%)∗ | 30 (21.3) | 41 (29.3) |
| Death, n | 2 | 4 |
| Progression or relapse, n | 24 | 33 |
| Other†, n | 4 | 4 |
| HR (95% CI) | 0.62 (0.38-1.00) | |
| 2-y rate (95% CI) | 74.2 (65.7-82.7) | 65.6 (56.4-74.8) |
| ORR at EOT, n (%)‡ | 127 (90.1) | 114 (81.4) |
| CR, n (%) | 116 (82.3) | 109 (77.9) |
| PR, n (%) | 11 (7.8) | 5 (3.6) |
| SD, n (%) | 3 (2.1) | 5 (3.6) |
| PD, n (%) | 4 (2.8) | 10 (7.1) |
| Nonevaluable | 1 (0.7) | 3 (2.1) |
| Not included/missing | 6 (4.3) | 8 (5.7) |
| OS events, n (%) | 10 (7.1) | 15 (10.7) |
| HR (95% CI) | 0.64 (0.29-1.42) | |
| 2-y rate (95% CI) | 91.1 (85.7-96.5) | 88.7 (82.6-94.8) |
| DFS events, n (%)§ | 20 (15.7) | 24 (21.1) |
| Unstratified HR (95% CI) | 0.67 (0.37-1.23) |
| Outcome . | Pola-R-CHP (n = 141) . | R-CHOP (n = 140) . |
|---|---|---|
| PFS, number of events (%)∗ | 30 (21.3) | 40 (28.6) |
| Death, n | 2 | 4 |
| Progression or relapse, n | 28 | 36 |
| HR (95% CI) | 0.64 (0.40-1.03) | |
| 2-y rate (95% CI) | 74.2 (65.7-82.7) | 66.5 (57.3-75.6) |
| EFS, number of events (%)∗ | 30 (21.3) | 41 (29.3) |
| Death, n | 2 | 4 |
| Progression or relapse, n | 24 | 33 |
| Other†, n | 4 | 4 |
| HR (95% CI) | 0.62 (0.38-1.00) | |
| 2-y rate (95% CI) | 74.2 (65.7-82.7) | 65.6 (56.4-74.8) |
| ORR at EOT, n (%)‡ | 127 (90.1) | 114 (81.4) |
| CR, n (%) | 116 (82.3) | 109 (77.9) |
| PR, n (%) | 11 (7.8) | 5 (3.6) |
| SD, n (%) | 3 (2.1) | 5 (3.6) |
| PD, n (%) | 4 (2.8) | 10 (7.1) |
| Nonevaluable | 1 (0.7) | 3 (2.1) |
| Not included/missing | 6 (4.3) | 8 (5.7) |
| OS events, n (%) | 10 (7.1) | 15 (10.7) |
| HR (95% CI) | 0.64 (0.29-1.42) | |
| 2-y rate (95% CI) | 91.1 (85.7-96.5) | 88.7 (82.6-94.8) |
| DFS events, n (%)§ | 20 (15.7) | 24 (21.1) |
| Unstratified HR (95% CI) | 0.67 (0.37-1.23) |
BICR, blinded independent central review; EOT, end of treatment; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
As assessed by investigator.
New antilymphoma therapy or positive biopsy.
As assessed by BICR.
Pola-R-CHP, n = 127; R-CHOP, n = 114. Patients with an investigator-assessed best response of CR at any time during the study were evaluable for DFS.