Study
| Double-blind, multicenter, randomised, phase 3 study (Keynote 859) |
| Previously untreated locally advanced/metastatic HER2 negative GEJ and gastric adenocancer |
| Pembrolizumab + Cht (n=790) vs. PBO + Cht (n=789) |
Efficacy
| ITT |
| mOS: 12.9 vs 11.5 mos, HR:0.78, p<0.001 |
| mPFS: 6.9 vs. 5.6 mos, HR:0.76, p<0.001 |
| CPS≥1 group: |
| mOS: 13.0 vs 11.4 mos, HR:0.74, p<0.001 |
| mPFS: 6.9 vs. 5.6 mos, HR:0.72, p<0.001 |
| CPS≥10 group: |
| mOS: 15.7 vs 11.8 mos, HR:0.65, p<0.001 |
| mPFS: 8.1 vs. 5.6 mos, HR:0.62, p<0.001 |
Safety
| Grade≥3 AEs: Neutropenia (9% vs.8%), anemia (9% vs.7%), thrombocytopenia (7% vs 5%). |
Lancet Oncol 2023; 24: 1181–95
http://doi.org/10.1016/S1470-2045(23)00515-6
Reviewed by Elvin Chalabiyev, MD on Nov 20, 2023
