KEYNOTE-789
11 evidence topics · 3 sources
Objective
Location and study date
Analysis data cutoffs
| Analysis | Quoted date |
|---|---|
| Final PFS testing | “December 3, 2021” |
| Final OS analysis | “January 17, 2023” |
Study design
Eligibility criteria
Eligible EGFR alterations
Treatment
Experimental and control additions to chemotherapy
Study outcomes
Rationale for using progression-free survival as a primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
Results
Participant disposition
Baseline characteristics
No evidence found.
Efficacy results
Comparator trial: primary efficacy conclusion
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
The PFS P value of 0.0122 did not meet the prespecified one-sided boundary of 0.0117. Neither primary efficacy endpoint was met. These results concern pembrolizumab plus chemotherapy, not ivonescimab, and cannot determine the effect of simultaneous PD-1 and VEGF inhibition.