Across 86 European CTIS-authorized ovarian, fallopian tube, and primary peritoneal cancer Phase II/III trial records, safety endpoints were the most widely measured endpoint family, appearing in 66 trials (76.7%). Progression-free survival (PFS) was the dominant primary endpoint family at 33 trials (38.4%), while secondary endpoint strategy was broader: safety appeared in 53 trials (61.6%), overall survival (OS) in 48 (55.8%), and PFS in 46 (53.5%).
At trial level, safety / adverse events (AEs) / tolerability appeared in 66 of 86 trials (76.7%), followed by PFS in 60 trials (69.8%) and OS in 55 trials (64.0%). Objective response rate (ORR) was also common, appearing in 39 trials (45.3%).
European ovarian cancer trials are not endpoint-sparse: 66/86 trials include safety, 60/86 include PFS, and 55/86 include OS, indicating that most CTIS submissions combine tolerability, disease-control, and survival evidence rather than relying on one endpoint family alone.
Structured primary endpoints appeared in 80 of 86 trials (93.0%). PFS was used as a primary endpoint family in 33 trials (38.4%), followed by safety / AEs / tolerability in 27 trials (31.4%) and ORR in 18 trials (20.9%).
| Endpoint family | Trials | % |
|---|---|---|
| PFS | 33/86 | 38.4% |
| Safety / AEs / tolerability | 27/86 | 31.4% |
| ORR | 18/86 | 20.9% |
| PD / biomarker / translational | 10/86 | 11.6% |
| OS | 6/86 | 7.0% |
Primary endpoint design is anchored in disease-control evidence: PFS appeared 1.8 times as often as ORR as a primary endpoint family (33 vs 18 trials). Safety remained prominent because Phase I/II and dose-expansion designs were included in the Phase II CTIS cohort.
Secondary endpoints appeared in 71 of 86 trials (82.6%), covering 424 endpoint items. Safety / AEs / tolerability appeared as a secondary endpoint family in 53 trials (61.6%), OS in 48 (55.8%), PFS in 46 (53.5%), ORR in 32 (37.2%), and duration of response (DOR) in 30 (34.9%).
The secondary layer is where ovarian cancer CTIS submissions add survival maturity, response durability, patient-reported outcomes, and safety support: OS appears in 48/86 trials as secondary compared with only 6/86 as primary.
Dedicated exploratory/other endpoint fields appeared in 7 of 86 trials (8.1%), covering 8 endpoint items. QoL / patient-reported outcomes (PROs) and PD / biomarker / translational endpoints each appeared in 3 trials (3.5%), while PFS, OS, and safety each appeared in 2 trials (2.3%).
| QoL / PRO | 3/86 | 3.5% |
| PD / biomarker / translational | 3/86 | 3.5% |
| Safety / AEs / tolerability | 2/86 | 2.3% |
| PFS | 2/86 | 2.3% |
| OS | 2/86 | 2.3% |
Exploratory evidence is present but not structurally dominant in the CTIS endpoint fields: only 7/86 trials used dedicated exploratory/other fields, with biomarker and PRO signals more common than additional survival endpoints.
The cohort included 36 Phase II trials (41.9%), 30 Phase III trials (34.9%), 18 Phase I/II trials (20.9%), and 2 Phase II/III bridge trials (2.3%). In pure Phase III trials, PFS appeared as a primary endpoint family in 18/30 trials (60.0%), compared with 12/36 pure Phase II trials (33.3%).