Efficacy summary in all exposed patients by IRF and INV
| . | By IRF . | By INV . |
|---|---|---|
| ORR∗, n (%) (95% CI) | 37 (42.0) (31.6-53.1) | 37 (42.0) (31.6-53.1) |
| CR rate∗, n (%) (95% CI) | 21 (23.9) (15.4-34.1) | 21 (23.9) (15.4-34.1) |
| Median time to first response, mo (range) | 1.4 (1.1-11.5) | 1.4 (1.1-8.9) |
| Duration of response | ||
| Median, mo (95% CI) | 7.0 (4.2-NE) | 6.9 (4.4-NE) |
| 12-mo event-free rate | 44.1% (27.3-60.9) | 43.2% (26.8-59.6) |
| Median time to first CR, mo (range) | 2.8 (1.1-17.5) | 3.0 (1.2-20.8) |
| Duration of CR | ||
| Median, mo (95% CI) | NE (9.0-NE) | NE (7.0-NE) |
| 12-mo event-free rate | 68.1% (46.9-89.3) | 72.0% (48.5-95.5) |
| Duration of response in complete responders | ||
| Median, mo (95% CI) | NE (9.0-NE) | NE (13.8-NE) |
| 12-mo event-free rate | 69.7% (49.3-90.1) | 79.0% (60.6-97.3) |
| PFS | ||
| Median, mo (95% CI) | 3.2 (2.2-5.3) | 2.7 (1.4-4.1) |
| 12-mo event-free rate | 22.6% (13.0-32.2) | 20.4% (11.6-29.2) |
| OS | ||
| Median, mo (95% CI) | 11.5 (9.0-16.4) | |
| 12-mo event-free rate | 48.1% (37.1-59.2) | |
| . | By IRF . | By INV . |
|---|---|---|
| ORR∗, n (%) (95% CI) | 37 (42.0) (31.6-53.1) | 37 (42.0) (31.6-53.1) |
| CR rate∗, n (%) (95% CI) | 21 (23.9) (15.4-34.1) | 21 (23.9) (15.4-34.1) |
| Median time to first response, mo (range) | 1.4 (1.1-11.5) | 1.4 (1.1-8.9) |
| Duration of response | ||
| Median, mo (95% CI) | 7.0 (4.2-NE) | 6.9 (4.4-NE) |
| 12-mo event-free rate | 44.1% (27.3-60.9) | 43.2% (26.8-59.6) |
| Median time to first CR, mo (range) | 2.8 (1.1-17.5) | 3.0 (1.2-20.8) |
| Duration of CR | ||
| Median, mo (95% CI) | NE (9.0-NE) | NE (7.0-NE) |
| 12-mo event-free rate | 68.1% (46.9-89.3) | 72.0% (48.5-95.5) |
| Duration of response in complete responders | ||
| Median, mo (95% CI) | NE (9.0-NE) | NE (13.8-NE) |
| 12-mo event-free rate | 69.7% (49.3-90.1) | 79.0% (60.6-97.3) |
| PFS | ||
| Median, mo (95% CI) | 3.2 (2.2-5.3) | 2.7 (1.4-4.1) |
| 12-mo event-free rate | 22.6% (13.0-32.2) | 20.4% (11.6-29.2) |
| OS | ||
| Median, mo (95% CI) | 11.5 (9.0-16.4) | |
| 12-mo event-free rate | 48.1% (37.1-59.2) | |
NE, not estimable.
Best response.