Clinical Trial Intelligence

Where Do OS and PFS Sit in Phase III Pancreatic Cancer Trials?

29 May 2026

Across 25 endpoint-bearing reviewed Phase III pancreatic cancer trials, overall survival was the dominant hard efficacy endpoint. PFS was rarely used without OS; when PFS appeared, it was usually paired with OS either as a co-primary/composite signal or as a secondary endpoint supporting the survival architecture.

25
Reviewed trials
44.0%
Used OS as primary endpoint
16.0%
Used PFS as primary endpoint
52.0%
Included both OS and PFS anywhere

Primary Endpoint Architecture

OS appeared as a primary endpoint in 44.0% of reviewed trials. PFS appeared as a primary endpoint in 16.0%, but half of that use was part of an OS/PFS co-primary or composite survival architecture rather than standalone PFS primacy.

Primary Endpoint Architecture
OS primary
36.0%
OS + PFS primary
8.0%
PFS primary
8.0%
DFS / EFS primary
16.0%
Other primary endpoint
32.0%
OS and PFS in Pancreatic Cancer Phase III Trials
Interpretation

The endpoint pattern is OS-led. PFS is present, but it more often functions as a paired or supporting endpoint than as the sole primary efficacy anchor.

OS and PFS Pairing

PFS did not appear as an isolated endpoint strategy in the reviewed dataset. Every trial with PFS also included OS somewhere in the endpoint architecture, while OS appeared without PFS in 24.0% of trials.

OS/PFS Pairing Pattern
OS + PFS
52.0%
OS without PFS
24.0%
PFS without OS
0.0%
Neither OS nor PFS
24.0%
OS and PFS in Pancreatic Cancer Phase III Trials
Interpretation

PFS appears operationally important but not independently dominant. The observed pattern treats PFS as a progression-control readout that usually needs the interpretive support of OS in Phase III pancreatic cancer designs.

Disease Setting Signal

Advanced, metastatic, or unresectable pancreatic cancer trials were much more likely to use OS or PFS as the primary efficacy anchor. Resected, resectable, or post-curative-intent trials more often shifted toward DFS or EFS, while still retaining OS as a secondary or supporting endpoint.

OS/PFS Primary Use by Disease Setting
Advanced / metastatic
81.8%
Resected / resectable
42.9%
Diagnostic / supportive
0.0%
OS and PFS in Pancreatic Cancer Phase III Trials
Interpretation

The setting signal is clear: metastatic or unresectable trials concentrate OS/PFS primary endpoints, while curative-intent or resected settings more often move the primary endpoint upstream to DFS or EFS.

Endpoint Layering

OS was present somewhere in 76.0% of reviewed trials, while PFS was present in 52.0%. DFS, EFS, or related recurrence endpoints appeared in 24.0%, mainly in post-surgical or potentially curative settings.

Endpoint Families Appearing Anywhere in the Trial
OS
76.0%
PFS
52.0%
DFS / EFS / MFS
24.0%
Neither OS nor PFS
24.0%
OS and PFS in Pancreatic Cancer Phase III Trials
Interpretation

Pancreatic cancer Phase III endpoint design is layered rather than binary. OS is the dominant interpretive endpoint, PFS is commonly paired with it, and DFS/EFS captures earlier disease-control logic in curative-intent settings.

Executive Interpretation

The observed CTIS dataset does not show PFS replacing OS as the central Phase III endpoint in pancreatic cancer. Instead, OS remains the main anchor, especially in advanced or metastatic disease, while PFS is used as a progression-control layer and DFS/EFS becomes more prominent when the trial setting moves closer to surgery, recurrence prevention, or curative-intent treatment.

Observed Pattern Summary
OS anchor
OS appeared somewhere in 76.0% of reviewed trials and was primary in 44.0%.
PFS pairing
PFS appeared in 52.0% of trials, but 0.0% used PFS without OS anywhere.
Disease setting
Advanced/metastatic trials showed 81.8% OS/PFS primary use versus 42.9% in resected/resectable settings.
Earlier disease control
DFS, EFS, or recurrence endpoints appeared in 24.0%, mainly around surgery or curative-intent designs.
OS and PFS in Pancreatic Cancer Phase III Trials
Interpretation

The data suggest a pragmatic endpoint hierarchy: OS for definitive survival impact, PFS for progression-control context, and DFS/EFS for earlier-stage recurrence-risk settings. The clearest pancreatic cancer signal is not OS versus PFS as substitutes, but OS as the anchor around which PFS and recurrence endpoints are layered.