Table 3a.
Efficacy outcomes in the PANGEA phase 2 trial by intention to treat.
| ITT (n=68) | non-ITT (n=12) | |
|---|---|---|
| Overall Survival* | ||
| Events | 56 (82%) | 11 (92%) |
| 1-year survival rate** | 66% | 33.3% |
| 2-year survival rate | 29% | 8% |
| Median Survival, months (95% CI) | 15.7 (13.4–17.7) | 9.0 (4.6–20.3) |
| Progression-Free Survival (PFS1)* | ||
| Events | 61 (90%) | 11 (92%) |
| Median duration, months (95% CI) | 8.2 (7.3–9.6) | 6.7 (2.9–10.6) |
| Overall Objective Response (ORR1) | ||
| Patients with measureable disease | 54 (79%) | 10 (83%) |
| Best overall response | ||
| Complete Response | 4 (7.4%) | 0 (0%) |
| Partial Response | 36 (66.7%) | 4 (40%) |
| Stable Disease | 13 (24.1%) | 3 (30%) |
| Progressive Disease | 1 (1.9%) | 3 (30%) |
| Objective Response | 40/54 (74.1%) | 4/10 (40%) |
| Disease Control (measureable) | 53/54 (98.1%) | 7/10 (70%) |
| Patient with non-measureable disease | 14 | 2 |
| Stable Disease | 14 (100%) | 2 (100%) |
| Progressive Disease | 0 (0%) | 0 (0%) |
| Overall Disease Control | 67/68 (98.5%) | 9/12 (75%) |
*
Median follow up among survivors was 27.6 months (IQR 24.8–40.5, range 16.6–57.6)
**
The primary efficacy endpoint was 1-year survival rate.
Abbreviations: ITT, intention to treat; PFS1, first-line progression-free survival; ORR1, first-line overall objective response rate.