Efficacy results in the overall iNHL population and FL and MZL subgroups (full analysis set)
| . | Overall iNHL . | HR (95% CI) . | P value . | |
|---|---|---|---|---|
| Copanlisib + R-B (n = 262) . | Placebo + R-B (n = 262) . | |||
| PFS per independent radiologic review | ||||
| Median PFS (95% CI), mo | 32.9 (24.4-38.6) | 33.3 (27.8-42.8) | 1.13 (0.88-1.44) | .83 |
| Objective tumor responses per independent radiologic review | ||||
| ORR, n (%) (95% CI) | 224 (85.5) (80.6-89.5) | 227 (86.6) (81.9-90.5) | — | — |
| DoR per independent radiologic review∗ | ||||
| Median DoR (95% CI), mo | 32.2 (22.8-38.8) | 32.4 (27.7-42.0) | 1.15 (0.88-1.48) | .85 |
| OS | ||||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) | 1.13 (0.80-1.60) | .76 |
| . | Overall iNHL . | HR (95% CI) . | P value . | |
|---|---|---|---|---|
| Copanlisib + R-B (n = 262) . | Placebo + R-B (n = 262) . | |||
| PFS per independent radiologic review | ||||
| Median PFS (95% CI), mo | 32.9 (24.4-38.6) | 33.3 (27.8-42.8) | 1.13 (0.88-1.44) | .83 |
| Objective tumor responses per independent radiologic review | ||||
| ORR, n (%) (95% CI) | 224 (85.5) (80.6-89.5) | 227 (86.6) (81.9-90.5) | — | — |
| DoR per independent radiologic review∗ | ||||
| Median DoR (95% CI), mo | 32.2 (22.8-38.8) | 32.4 (27.7-42.0) | 1.15 (0.88-1.48) | .85 |
| OS | ||||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) | 1.13 (0.80-1.60) | .76 |
| . | FL . | HR (95% CI) . | P value . | |
|---|---|---|---|---|
| Copanlisib + R-B (n = 175) . | Placebo + R-B (n = 177) . | |||
| PFS per independent radiologic review | ||||
| Median PFS (95% CI), mo | 22.4 (19.1-33.4) | 33.1 (27.6-47.0) | 1.29 (0.97-1.73) | .96 |
| Objective tumor responses per independent radiologic review | ||||
| ORR, n (%) (95% CI) | 147 (84.0) (77.7-89.1) | 155 (87.1) (81.2-91.6) | — | — |
| DoR per independent radiologic review∗ | ||||
| Median DoR (95% CI), mo | 22.8 (16.8-33.3) | 32.3 (25.5-45.0) | 1.31 (0.96-1.77) | .96 |
| OS | ||||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) | 1.18 (0.77-1.82) | .78 |
| . | FL . | HR (95% CI) . | P value . | |
|---|---|---|---|---|
| Copanlisib + R-B (n = 175) . | Placebo + R-B (n = 177) . | |||
| PFS per independent radiologic review | ||||
| Median PFS (95% CI), mo | 22.4 (19.1-33.4) | 33.1 (27.6-47.0) | 1.29 (0.97-1.73) | .96 |
| Objective tumor responses per independent radiologic review | ||||
| ORR, n (%) (95% CI) | 147 (84.0) (77.7-89.1) | 155 (87.1) (81.2-91.6) | — | — |
| DoR per independent radiologic review∗ | ||||
| Median DoR (95% CI), mo | 22.8 (16.8-33.3) | 32.3 (25.5-45.0) | 1.31 (0.96-1.77) | .96 |
| OS | ||||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) | 1.18 (0.77-1.82) | .78 |
| . | MZL . | HR (95% CI) . | P value . | |
|---|---|---|---|---|
| Copanlisib + R-B (n = 43) . | Placebo + R-B (n = 49) . | |||
| PFS per independent radiologic review | ||||
| Median PFS (95% CI), mo | 63.8 (30.7-NE) | 41.0 (22.0-NE) | 0.73 (0.37-1.42) | .17 |
| Objective tumor responses per independent radiologic review | ||||
| ORR, n (%) (95% CI) | 39 (90.7) (77.9-97.4) | 43 (87.8) (75.2-95.4) | — | — |
| DoR per independent radiologic review∗ | ||||
| Median DoR (95% CI), mo | 60.9 (21.9-NE) | 47.3 (19.8-NE) | 0.80 (0.39-1.65) | .28 |
| OS | ||||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) | 0.92 (0.42-2.04) | .42 |
| . | MZL . | HR (95% CI) . | P value . | |
|---|---|---|---|---|
| Copanlisib + R-B (n = 43) . | Placebo + R-B (n = 49) . | |||
| PFS per independent radiologic review | ||||
| Median PFS (95% CI), mo | 63.8 (30.7-NE) | 41.0 (22.0-NE) | 0.73 (0.37-1.42) | .17 |
| Objective tumor responses per independent radiologic review | ||||
| ORR, n (%) (95% CI) | 39 (90.7) (77.9-97.4) | 43 (87.8) (75.2-95.4) | — | — |
| DoR per independent radiologic review∗ | ||||
| Median DoR (95% CI), mo | 60.9 (21.9-NE) | 47.3 (19.8-NE) | 0.80 (0.39-1.65) | .28 |
| OS | ||||
| Median OS (95% CI), mo | NE (NE-NE) | NE (NE-NE) | 0.92 (0.42-2.04) | .42 |
NE, not estimable.
Includes patients with responses in the full analysis set.