TABLE 4.
Summary of Selected Phase II/Phase III Trials Containing Vandetanib Monotherapy Arms and Clinical Outcome
| Trials with Vandetanib Monotherapy Arms |
Trial Phase |
Median PFS (mo) |
HR p |
Median OS (mo) |
HR p |
|---|---|---|---|---|---|
| Current trial | II | 1.81 | N/A | 6.5 | N/A |
| EGFR mutation | 3.2 | 5.9 | |||
| ZEPHYR | III | ||||
| Lee et al.11 | |||||
| Vandetanib arm | 1.9 | 0.63 | 8.5 | 0.95 | |
| Placebo arm | 1.8 | p < 0.001 | 7.8 | p = 0.527 | |
| Natale et al.2 | III | ||||
| Vandetanib arm | 2.6 | 0.98 | 6.9 | 1.01 | |
| Erlotinib arm | 2.0 | p = 0.72 | 7.8 | p = 0.83 | |
| Natale et al.10 | II | ||||
| Vandetanib arm | 2.75a | 0.69a | 6.1 | 1.19 | |
| Gefitinib arm | 2.03a | p = 0.025 | 7.4 | p = 0.34 |
Results reported are before cross-over.
PFS, progression-free survival; HR, hazard ratio; OS, overall survival; N/A, not applicable; ZEPHYR, International, Randomised, Double-Blind Parallel Group, Multicenter Study to Assess the Efficacy of ZD6474 (ZACTIMA) plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB–IV) Non-Small Cell Lung cancer (NSCLC) after Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI).