Table 1.
Clinical trials reporting PFS outcomes data for TKI monotherapies and antiangiogenic/TKI combinations by EGFR-activating mutation.
| Ex19del | Ex21L858R | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Geography | Size (N) | CNSc (%) | Median PFS vs. control (months) | Δ mPFS | HR (95% CI) | 1-year PFS rates vs. control | Median PFS vs. control (months) | Δ mPFS | HR (95% CI) | 1-year PFS rates vs. control |
| TKI monotherapy | |||||||||||
| FLAURAa (Ph3 osimertinib vs. gefitinib or erlotinib; ref. 38) | Global | 556 | 19/23 | 21.4 vs. 11.0 | 10.4 | 0.43 (0.32–0.56) | 70% vs. 43% | 14.4 vs. 9.5 | 4.9 | 0.51 (0.36–0.71) | 59% vs. 38% |
| ARCHER 1050a (Ph3 dacomitinib vs. gefitinib; ref. 39) | East Asia/EU | 452 | Excl | 16.5 vs. 9.2 | 7.3 | 0.55 (0.41–0.75) | 59% vs. 35% | 12.3 vs. 9.8 | 2.5 | 0.63 (0.44–0.88) | 51% vs. 38% |
| LUX-Lung 3 (Ph3 afatinib vs. cisplatin plus pemetrexed; ref. 40) | Global | 345 | NR | 13.8 vs. 5.6 | 8.1 | 0.28 (0.18–0.44) | NA | 10.8 vs. 8.1 | 2.7 | 0.75 (0.48–1.19) | NA |
| LUX-Lung 6 (Ph3 afatinib vs. cisplatin plus gemcitabine; ref. 41) | East Asia | 364 | NR | 13.1 vs. 5.6 | 8.1 | 0.20 (0.13–0.33) | NA | 9.6 vs. 5.6 | 4.0 | 0.31 (0.19–0.52) | NA |
| LUX-Lung 7 (RPh2 afatinib vs. gefitinib; ref. 42) | International | 319 | 16/15 | 12.7 vs. 11.0 | 1.7 | 0.76 (0.55–1.06) | 51% vs. 42% | 10.9 vs. 10.8 | 0.1 | 0.71 (0.47–1.06) | 42% vs. 39% |
| WJTOG3404 (Ph3 gefitinib vs. cisplatin plus docetaxel; ref. 43) | Japan | 177 | NR | 9.0 vs. 6.0 | 3.0 | 0.45 (0.27–0.77) | NA | 9.6 vs. 6.7 | 2.9 | 0.51 (0.29–0.90) | NA |
| EURTACa (erlotinib vs. cisplatin plus docetaxel or gemcitabine; ref. 44) | EU | 173 | 10/13 | 11.0 vs. 4.6 | 6.4 | 0.30 (0.18–0.50) | 47% vs. 11% | 8.4 vs. 6.0 | 2.4 | 0.55 (0.29–1.02) | 29% vs. 10% |
| Antiangiogenics + TKI | |||||||||||
| RELAYb (RPh3 ramucirumab ± erlotinib; ref. 19) | Global | 449 | Excl | 19.6 vs. 12.5 | 7.1 | 0.65 (0.47–0.90) | 74% vs. 54% | 19.4 vs. 11.2 | 8.2 | 0.62 (0.44–0.87) | 70% vs. 47% |
| NEJ.026a (Ph3 erlotinib ± bevacizumab; Japan; ref. 17) | Japan | 228 | 32/32 | 16.6 vs. 12.4 | 4.2 | 0.69 (0.41–1.16) | 71% vs. 46% | 17.4 vs. 13.7 | 3.7 | 0.57 (0.33–0.97) | 70% vs. 58% |
| JO25567a (RPh2 erlotinib ± bevacizumab; ref. 16) | Japan | 154 | Excl | 18.0 vs. 10.3 | 7.7 | 0.41 (0.24–0.72) | 78% vs. 29% | 13.9 vs. 7.1 | 6.8 | 0.67 (0.38–1.18) | 75% vs. 39% |
| CTONG.1509a,b (Ph3 erlotinib ± bevacizumab; ref. 18) | China | 311 | 28/30 | 18.0 vs. 12.6 | 5.4 | 0.63 (0.44–0.92) | 79% vs. 60% | 18.0 vs. 9.7 | 8.3 | 0.50 (0.34–0.74) | 75% vs. 37% |
Abbreviations: Excl, excluded; mPFS, median progression-free survival; NA, not available; NR, not reported.
a1-year PFS rates estimated from published Kaplan–Meier survival curves.
bInvestigator-assessed PFS.
cCNS metastasis as presented at baseline.