Table 3.
Main characteristics from the phase III trials in MTC with vandetanib and cabozantinib.
| ZETA [83] | EXAM [84] | |
|---|---|---|
| Study design | Randomized (2:1), double blind, placebo-controlled, phase III | Randomized (2:1), double blind, placebo-controlled, phase III |
| Experimental arm | Vandetanib 300mg/24h | Cabozantinib 140 mg/24 h |
| Target | VEGFR, EGFR, RET | MET, VEGFR2, FLT3, cKIT and RET |
| Number of patients | 331 | 330 |
| Tumor stage | Unresectable/Metastatic | Unresectable/Metastatic Documented RECIST progression |
| Previous treatment lines | 132 (40%) previously treated | 128 (40%) previously treated |
| RET mutational status: RET+/RET-/RET unknown | 56% (187)/2.4% (8)/41% (136) | 48% (159)/12% (41)/39% (130) |
| Primary endpoint | PFS | PFS |
| Progressive disease | Not mandatory | Yes |
| Overall Response Rate | 45% vs. 13% | 28% vs. 0% |
| Disease Control Rate | 87% vs. 71% | 55.3% vs. 13.5% |
| Progression Free Survival (PFS) | 30.5 m vs. 19.3 m (HR 0.27) | 11.2 m vs. 4 m (HR 0.28) |
PFS: progression free survival.