Summary of efficacy results by IRC assessment in the overall population, in patients with CR, and by pLOT
| . | Overall N = 103 . | Patients with CR by IRC, n = 63 . | Patients with 1 pLOT, n = 39 . | Patients with ≥2 pLOT, n = 64 . |
|---|---|---|---|---|
| Time to response, median (range), mo | 1.5 (0.9-3.0) | 1.4 (0.9-3.0) | 1.5 (1.1-2.8) | 1.4 (0.9-3.0) |
| Time to CR, median (range), mo | 2.6 (1.3-22.1) | 2.6 (1.3-22.1) | 1.6 (1.3-22.1) | 2.8 (1.4-11.2) |
| Patients remaining in response at 12 mo,∗ % | 47.6 (32.8-61.1) | 63.5 (43.5-78.1) | 58.9 (29.5-79.5) | 40.4 (23.9-56.3) |
| Patients remaining in CR at 12 mo,∗ % | 62.6 (42.3-77.5) | 62.6 (42.3-77.5) | 61.7 (24.5-84.7) | 62.1 (39.9-78.1) |
| PFS at 12 mo,∗ % | 44.0 (31.7-55.5) | 68.5 (50.0-81.3) | 63.2 (40.1-79.4) | 32.8 (19.0-47.2) |
| OS at 12 mo,∗ % | 56.6 (45.5-66.3) | 84.4 (70.8-92.0) | 69.1 (49.3-82.4) | 49.6 (36.0-61.8) |
| . | Overall N = 103 . | Patients with CR by IRC, n = 63 . | Patients with 1 pLOT, n = 39 . | Patients with ≥2 pLOT, n = 64 . |
|---|---|---|---|---|
| Time to response, median (range), mo | 1.5 (0.9-3.0) | 1.4 (0.9-3.0) | 1.5 (1.1-2.8) | 1.4 (0.9-3.0) |
| Time to CR, median (range), mo | 2.6 (1.3-22.1) | 2.6 (1.3-22.1) | 1.6 (1.3-22.1) | 2.8 (1.4-11.2) |
| Patients remaining in response at 12 mo,∗ % | 47.6 (32.8-61.1) | 63.5 (43.5-78.1) | 58.9 (29.5-79.5) | 40.4 (23.9-56.3) |
| Patients remaining in CR at 12 mo,∗ % | 62.6 (42.3-77.5) | 62.6 (42.3-77.5) | 61.7 (24.5-84.7) | 62.1 (39.9-78.1) |
| PFS at 12 mo,∗ % | 44.0 (31.7-55.5) | 68.5 (50.0-81.3) | 63.2 (40.1-79.4) | 32.8 (19.0-47.2) |
| OS at 12 mo,∗ % | 56.6 (45.5-66.3) | 84.4 (70.8-92.0) | 69.1 (49.3-82.4) | 49.6 (36.0-61.8) |
Kaplan-Meier estimates are shown with 95% CIs.