Table 5.
Efficacy outcomes in Parts 1 and 2 (modified intention-to-treat analysis set)
| Outcome | Parameter | Trial part 1 | Trial part 2 | ||||
| Group A (N=31) |
Group B (N=29) |
Group C (N=30) |
Group B (N=20) |
Group C (N=13) |
|||
| PFS | Disease progression | n (%) | 15 (48.4) | 8 (27.6) | 15 (50.0) | 7 (35.0) | 3 (23.1) |
| Time to event, months | Median (95% CI) | 20.3 (15.7 to NA) | NA (24.6 to NA) | 21.4 (12.6 to NA) | NA (18.4 to NA) | NA (6.9 to NA) | |
| At 1 year | KM (95% CI) | 83% (64% to 92%) | 90% (71% to 97%) | 89% (71% to 96%) | 85% (60% to 95%) | 83% (48% to 96%) | |
| At 2 years | KM (95% CI) | 47% (28% to 64%) | 75% (55% to 87%) | 46% (27% to 63%) | 65% (40% to 82%) | 74% (39% to 91%) | |
| Data maturity | Total events (%) | 38 (42.2) | – | – | 10 (30.3) | ||
| HR vs Group C (95% CI) | 0.98 (0.48 to 2.00) | 0.39 (0.16 to 0.96) | – | 1.29 (0.33 to 4.99) | – | ||
| Log-rank p value | 0.9483 | 0.0336 | – | 0.7125 | – | ||
| PFIBIO | Biological progression | n (%) | 2 (6.5) | 1 (3.4) | 2 (6.7) | – | – |
| Time to event, months | Median (95% CI) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | – | – | |
| At 1 year | KM (95% CI) | 100% (100% to 100%) | 100% (100% to 100%) | 100% (100% to 100%) | – | – | |
| At 2 years | KM (95% CI) | 91% (68% to 98%) | 96% (74% to 99%) | 89% (63% to 97%) | – | – | |
| Data maturity | Total events (%) | 5 (5.6) | – | – | – | – | |
| HR vs Group C (95% CI) | 0.89 (0.13 to 6.31) | 0.35 (0.03 to 3.87) | – | – | – | ||
| Log-rank p value | 0.9055 | 0.3704 | – | – | – | ||
| PFIBIO | Biological progression | n () | 10 (32.3) | 4 (13.8) | 7 (23.3) | – | – |
| Time to event, months | Median (95% CI) | 24.4 (24.1 to NA) | NA (NA to NA) | NA (NA to NA) | – | – | |
| At 1 year | KM (95% CI) | 86% (67% to 95%) | 93% (74% to 98%) | 93% (74% to 98%) | – | – | |
| At 2 years | KM (95% CI) | 71% (51% to 85%) | 84% (63% to 94%) | 72% (50% to 86%) | – | – | |
| Data maturity | Total events (%) | 21 (23.3) | – | – | – | – | |
| HR vs Group C (95% CI) | 1.14 (0.42 to 3.08) | 0.51 (0.15 to 1.74) | – | – | – | ||
| Log-rank p value | 0.7963 | 0.2723 | – | – | – | ||
| Remission | At 6 months | n (%) | 25 (80.6) | 28 (96.6) | 25 (83.3) | – | – |
| At 1 year | n (%) | 20 (64.5) | 23 (79.3) | 17 (56.7) | – | – | |
| OS | Deaths | n (%) | 12 (38.7) | 6 (20.7) | 13 (43.3) | – | – |
| Time to event, months | Median (95% CI) | NA (59 to NA) | NA (NA to NA) | NA (34.9 to NA) | – | – | |
| At 1 year | KM (95% CI) | 97% (79% to 100%) | 97% (78% to 100%) | 97% (79% to 100%) | – | – | |
| At 2 years | KM (95% CI) | 87% (69% to 95%) | 97% (78% to 100%) | 87% (68% to 95%) | – | – | |
| At 3 years | KM (95% CI) | 81% (62% to 91%) | 93% (75% to 98%) | 67% (47% to 80%) | – | – | |
| At 4 years | KM (95% CI) | 71% (52% to 84%) | 79% (60% to 90%) | 63% (44% to 78%) | – | – | |
| At 5 years | KM (95% CI) | 67% (48% to 81%) | 79% (60% to 90%) | 57% (37% to 72%) | – | – | |
| Data maturity | Total events (%) | 31 (34.4) | – | – | – | – | |
| HR vs Group C (95% CI) | 0.84 (0.38 to 1.84) | 0.40 (0.15 to 1.06) | – | – | – | ||
| Log-rank p value | 0.6631 | 0.0557 | – | – | – | ||
Group A, DCVAC/OvCa in parallel with chemotherapy (CT); Group B, CT and sequential DCVAC/OvCa; Group C, CT only; KM, Kaplan-Meier; OS, overall survival; PFIBIO, biological progression-free interval; PFS, progression-free survival.