Table 3.
Clinical outcomes by baseline EGFR-activating mutation subgroup and by treatment arms.
| Ex19del | Ex21L858R | |||
|---|---|---|---|---|
| RAM+ERL | PBO+ERL | RAM+ERL | PBO+ERL | |
| Duration of therapya | ||||
| n | 122 | 120 | 97 | 105 |
| Ramucirumab/placebo | ||||
| Event rates, n (%) | 85 (70) | 94 (78) | 70 (72) | 88 (84) |
| Censoring rates, n (%) | 37 (30) | 26 (22) | 27 (28) | 17 (16) |
| Median, months (95% CI) | 12.4 (9.4–14.8) | 11.0 (8.5–12.4) | 12.7 (8.0–15.1) | 8.8 (6.8–11.1) |
| Erlotinib | ||||
| Event rates, n (%) | 85 (70) | 94 (78) | 70 (72) | 88 (84) |
| Censoring rates, n (%) | 37 (30) | 26 (22) | 27 (28) | 17 (16) |
| Median, months (95% CI) | 15.2 (12.9–19.5) | 12.0 (10.6–13.8) | 15.1 (12.7–19.5) | 10.4 (7.7–12.4) |
| Overall response rate | ||||
| n | 123 | 120 | 99 | 105 |
| ORR, % (95% CI) | 79 (72–86) | 83 (76–89) | 74 (65–82) | 66 (57–75) |
| Disease control rate | ||||
| n | 123 | 120 | 99 | 105 |
| DCR, % (95% CI) | 96 (92–99) | 96 (92–99) | 95 (91–99) | 95 (91–99) |
| Time-to-response | ||||
| n | 97 | 99 | 73 | 69 |
| Median, months (95% CI) | 1.4 (1.3–2.6) | 1.4 (1.3–1.7) | 1.5 (1.4–1.7) | 1.4 (1.3–1.6) |
| Duration of response | ||||
| n | 97 | 99 | 73 | 69 |
| Event rates, n (%) | 53 (55) | 75 (76) | 48 (66) | 53 (77) |
| Censoring rates, n (%) | 44 (45) | 24 (24) | 25 (34) | 16 (23) |
| Median, months (95% CI) | 18.2 (13.8–20.9) | 11.0 (9.7–12.3) | 16.2 (12.5–20.1) | 11.1 (9.7–12.7) |
| Hazard ratio (95% CI) | 0.54 (0.38–0.77) | 0.73 (0.49–1.08) | ||
| Interim OS | ||||
| n | 123 | 120 | 99 | 105 |
| Event rates, n (%) | 21 (17) | 15 (13) | 16 (16) | 27 (26) |
| Censoring rates, n (%) | 102 (83) | 105 (88) | 83 (84) | 78 (74) |
| Median, months | NR | NR | NR | NR |
| Hazard ratio (95% CI) | 1.44 (0.74–2.80) | 0.61 (0.33–1.14) | ||
| 1-year OS rate, % (95% CI) | 94 (88–97) | 94 (88–97) | 92 (84–96) | 93 (86–97) |
| 2-year OS rate, % (95% CI) | 83 (74–89) | 87 (78–93) | 84 (74–90) | 71 (58–80) |
Abbreviations: DCR, disease control rate; NR, not reached.
aDuration of therapy is censored at the last date of study treatment for patients who remain on study treatment (ex19del: n = 122 RAM+ERL vs. 120 PBO+ERL and ex21L858R: n = 97 RAM+ERL vs. 105 PBO+ERL patients).