Efficacy summary in all patients with previously untreated DLBCL (ITT population)
| . | Pola-M-CHP, n = 40 . | Pola-R-CHP, n = 22 . |
|---|---|---|
| IRC-assessed objective response | ||
| CR rate∗, n (%) | 29 (72.5) | 17 (77.3) |
| 95% CI | 56.1-85.4 | 54.6-92.2 |
| IRC-assessed ORR∗, n (%) | 30 (75.0) | 19 (86.4) |
| 95% CI | 58.8-87.3 | 65.1-97.1 |
| Response assessment at PRA∗ (investigator assessed) | ||
| ORR, n (%) | 32 (80.0) | 17 (77.3) |
| 95% CI | 64.4-91.0 | 54.6-92.2 |
| CR rate, n (%) | 30 (75.0) | 15 (68.2) |
| 95% CI | 58.8-87.3 | 45.1-86.1 |
| Partial response, n (%) | 2 (5.0) | 2 (9.1) |
| Progressive disease, n (%) | 1 (2.5) | 5 (22.7) |
| Stable disease, n (%) | 0 | 0 |
| Missing or not done, n (%) | 7 (17.5) | 0 |
| Best overall response (investigator assessed)† | ||
| ORR, n (%) | 34 (85.0) | 21 (95.5) |
| 95% CI | 70.2-94.3 | 77.2-99.9 |
| CR rate, n (%) | 31 (77.5) | 18 (81.8) |
| 95% CI | 61.6-89.2 | 59.7-94.8 |
| Investigator-assessed DoR† | ||
| Median (95% CI), mo | NE (16.2-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 75.0 (60.0-90.0) | 85.7 (70.8-100) |
| 24 months | 71.4 (55.6-87.3) | 80.7 (63.6-97.7) |
| Investigator-assessed PFS† | ||
| Median (95% CI), mo | NE (NE-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 70.8 (55.6-86.1) | 81.8 (65.7-97.9) |
| 24 months | 70.8 (55.6-86.1) | 81.8 (65.7-97.9) |
| PFS HR (95% CI) | 1.27 (0.44-3.68) | |
| P value | .66 | |
| Investigator-assessed EFS† | ||
| Median EFS (95% CI), mo | NE (27.8-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 69.1 (53.8-84.3) | 81.8 (65.7-97.9) |
| 24 months | 69.1 (53.8-84.3) | 81.8 (65.7-97.9) |
| EFS HR (95% CI) | 1.46 (0.51-4.17) | |
| P value | .48 | |
| Overall survival | ||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 86.3 (75.2-97.5) | 100.0 (100.0-100.0) |
| 24 months | 86.3 (75.2-97.5) | 86.4 (72.0-100.0) |
| OS HR (95% CI) | 1.02 (0.24-4.31) | |
| P value | .97 | |
| . | Pola-M-CHP, n = 40 . | Pola-R-CHP, n = 22 . |
|---|---|---|
| IRC-assessed objective response | ||
| CR rate∗, n (%) | 29 (72.5) | 17 (77.3) |
| 95% CI | 56.1-85.4 | 54.6-92.2 |
| IRC-assessed ORR∗, n (%) | 30 (75.0) | 19 (86.4) |
| 95% CI | 58.8-87.3 | 65.1-97.1 |
| Response assessment at PRA∗ (investigator assessed) | ||
| ORR, n (%) | 32 (80.0) | 17 (77.3) |
| 95% CI | 64.4-91.0 | 54.6-92.2 |
| CR rate, n (%) | 30 (75.0) | 15 (68.2) |
| 95% CI | 58.8-87.3 | 45.1-86.1 |
| Partial response, n (%) | 2 (5.0) | 2 (9.1) |
| Progressive disease, n (%) | 1 (2.5) | 5 (22.7) |
| Stable disease, n (%) | 0 | 0 |
| Missing or not done, n (%) | 7 (17.5) | 0 |
| Best overall response (investigator assessed)† | ||
| ORR, n (%) | 34 (85.0) | 21 (95.5) |
| 95% CI | 70.2-94.3 | 77.2-99.9 |
| CR rate, n (%) | 31 (77.5) | 18 (81.8) |
| 95% CI | 61.6-89.2 | 59.7-94.8 |
| Investigator-assessed DoR† | ||
| Median (95% CI), mo | NE (16.2-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 75.0 (60.0-90.0) | 85.7 (70.8-100) |
| 24 months | 71.4 (55.6-87.3) | 80.7 (63.6-97.7) |
| Investigator-assessed PFS† | ||
| Median (95% CI), mo | NE (NE-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 70.8 (55.6-86.1) | 81.8 (65.7-97.9) |
| 24 months | 70.8 (55.6-86.1) | 81.8 (65.7-97.9) |
| PFS HR (95% CI) | 1.27 (0.44-3.68) | |
| P value | .66 | |
| Investigator-assessed EFS† | ||
| Median EFS (95% CI), mo | NE (27.8-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 69.1 (53.8-84.3) | 81.8 (65.7-97.9) |
| 24 months | 69.1 (53.8-84.3) | 81.8 (65.7-97.9) |
| EFS HR (95% CI) | 1.46 (0.51-4.17) | |
| P value | .48 | |
| Overall survival | ||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) |
| Event-free rate (95% CI), % | ||
| 12 months | 86.3 (75.2-97.5) | 100.0 (100.0-100.0) |
| 24 months | 86.3 (75.2-97.5) | 86.4 (72.0-100.0) |
| OS HR (95% CI) | 1.02 (0.24-4.31) | |
| P value | .97 | |