Table 1.

Key clinical trials for GEA

TargetTrial (reference)PhaseLine of therapyTreatmentORR (%)Median OS (months)Median PFS (months)
HER2ToGA (59)III1L, HER2+Cisplatin/fluoropyrimidine + trastuzumab4713.86.7
Cisplatin/fluoropyrimidine3511.15.5
P = 0.0046
HER2JACOB (62)III1L, HER2+Chemotherapy + trastuzumab + pertuzumab5717.58.5
Chemotherapy + trastuzumab4814.27
P = 0.057 NS
HER2TRIO-013/LOGiC (66)III1L, HER2+CapeOx + lapatinib5312.26
CapeOx3910.55.4
P = 0.3492 NS
HER2TyTAN (67)III2L, HER2+Paclitaxel + lapatinib2711.05.4
Paclitaxel98.94.4
P = 0.1044 NS
HER2GATSBY (65)II/III2L, HER2+T-DM1217.92.7
Paclitaxel or docetaxel208.62.9
P = 0.86 NS
EGFREXPAND (85)III1LCisplatin/capecitabine + cetuximab309.44.4
Cisplatin/capecitabine2910.75.6
P = 0.32 NS
primary endpoint
EGFRREAL3 (86)III1LEOC + panitumumab468.86
EOC4211.37.4
P = 0.013 NS
EGFRCOG (87)III2LGefitinib2.73.71.6
Placebo0.43.71.2
P = 0.29 NS
METMETGastric (94)(early termination)III1L, MET+, HER2-mFOLFOX6 + onartuzumab4611.06.7
mFOLFOX64111.36.8
P = 0.24 NS
HGFRILOMET-1 (96)(early termination)III1L, MET+ECX + rilotumumab308.85.6
ECX4510.76
P = 0.032 NS
METAMG 337 (97)(early termination)II≥2L for 98% of patients, MET+AMG 33718 primary endpoint7.93.4
mTORGRANITE-1 (99)III≥2LEverolimus4.55.41.7
Placebo2.14.31.4
P = 0.124 NS
FGFR1/2/3SHINE (103)II2L, FGFR2+AZD45472.65.51.8
Paclitaxel236.63.5
P = 0.9581 NS
primary endpoint
VEGFAAVAGAST (107)III1LCisplatin/fluoropyrimidine + bevacizumab4612.16.7
Cisplatin/fluoropyrimidine3710.15.3
P = 0.1002 NS
VEGFR2RAINFALL (106)III1LCisplatin/fluoropyrimidine + ramucirumab4111.25.7
Cisplatin/fluoropyrimidine3610.75.4
P = 0.0106 (investigator review)
P = 0.74 NS (central independent review)primary endpoint
VEGFR2REGARD (104)III2LRamucirumab35.22.1
Placebo33.81.3
P = 0.047
VEGFR2RAINBOW (105)III2LPaclitaxel + ramucirumab289.64.4
Paclitaxel167.42.9
P = 0.017
PD-1KEYNOTE-061 (114)III2LPembrolizumabCPS≥1:CPS≥1:CPS≥1:
Paclitaxel169.11.5
148.34.1
P = 0.0421 NSOS and PFS in CPS ≥ 1 are both primary endpointsP = Not reportedOS and PFS in CPS≥1 are both primary endpoints
PD-1KEYNOTE- 059 (112)II≥3L, gastric/GEJPembrolizumab (Cohort 1)CPS≥1: 15.5CPS≥1: 5.8CPS≥1: 2.1
CPS<1: 6.4CPS<1: 4.9CPS<1: 2.0
Primary endpoint
PD-1KEYNOTE- 180 (115)II≥3L, ESCC/EAC/GEJPembrolizumabESCC: 14.3ESCC: 6.8ESCC: 2.1
EAC/GEJ: 5.2EAC/GEJ: 3.9EAC/GEJ: 1.9
primary endpoint
PD-1ATTRACTION-2 (113)III≥3LNivolumab115.31.6
Placebo04.11.5
P < 0.0001
PARPGOLD (129)III2LPaclitaxel + olaparib248.83.7
Paclitaxel166.93.2
P = 0.026 NS
  • NOTE: Primary endpoint is median OS unless otherwise specified.

  • Abbreviations: CapeOx, capecitabine/oxaliplatin; CPS, PD-L1 combined positive score; ECX, epirubicin/cisplatin/capecitabine; EOC, epirubicin/oxaliplatin/capecitabine; mFOLFOX6, leucovorin/fluorouracil/oxaliplatin; NS, not significant; ORR, objective response rate.