Table 1.
Clinical studies for evaluating chemotherapy for gastric cancer with master protocols
| Study name | VIKTORY | PANGEA |
|---|---|---|
| Year | 2018 | 2021 |
| Phase | III | II |
| Previous treatment | Presence (2nd-line) | Absence |
| Number of participants |
715 (1st-line) 460 (2nd-line) |
80 |
| Number of participants with biomarker-driven treatment | 105 | 68 |
| Age, median (range, year) | 61 (28–81) | |
| Gender, male/female/NA | 64/16 | |
| Subgroup | ||
| RAS (mutation or amplification) or MEK signature (high or low) | 25 | – |
| TP53 | 25 (mutation) | – |
| PIK3CA | 4 (mutation or amplification) | 20 (MAPK/PIK3CA aberrant) |
| MET | 24 (amplification)/4 (3 + by IHC) | – |
| TSC2 | 2 (null) | – |
| RICTOR | 1 (amplification) | – |
| MSI-High | – | 1 |
| PD-L1 | – | 4 (CPS > = 10) |
| EBV positive | – | 0 |
| Tumor-mutation burden | – | 0 |
| HER2 | – | 16 (amplification) |
| EGFR | – | 8 (amplification)/9 (overexpressed) |
| FGFR2 | – | 1 (amplification) |
| All negative | – | 9 |
| Historical control | 266 | 12 |
| Treatment | ||
| RAS (mutation or amplification) or MEK signature (high or low) | Selumetinib + docetaxel | – |
| TP53 | Adavosertib + paclitaxel | – |
| PIK3CA | Capivasertib + paclitaxel | Ramucirumab + mFOLFOX6 |
| MET | Savolitinib, or savolitinib + docetaxel | mFOLFOX6 (none available) |
| TSC2 | Vistusertib + paclitaxel | – |
| RICTOR | Vistusertib + paclitaxel | – |
| MSI-High | – | Nivolumab + mFOLFOX6 |
| PD-L1 | – | Nivolumab + mFOLFOX6 |
| EBV positive | – | Nivolumab + mFOLFOX6 |
| Tumor-mutation burden | – | Nivolumab + mFOLFOX6 |
| HER2 | – | Trastuzumab + mFOLFOX6 |
| EGFR | – | ABT-806 + mFOLFOX6 |
| FGFR2 | – | Bemarituzumab + mFOLFOX6 |
| All negative | – | Ramucirumab + mFOLFOX6 |
| Historical control | Taxol/ramucirumab (n = 99), taxane-based (n = 105), irinotecan-based (n = 62) | mFOLFOX6 |
|
Progression-free survival Biomarker-specific vs. conventional (median) |
5.7 months vs. 3.8 months | 8.2 months vs. 6.7 months |
|
Overall survival Biomarker-specific vs. conventional (median) |
9.8 months vs. 6.9 months | 15.7 months vs. 9.0 months |
MSI-H microsatellite instability high, CPS combined positivity score, EBV Epstein–Barr virus, TMB tumor-mutation burden, mFOLFOX modified FOLFOX