Table 2.
Secondary endpoints in the Taiwanese subgroup and the overall RELAY ITT population
| Taiwanese subgroup | Overall RELAY ITT populationa | |||||
|---|---|---|---|---|---|---|
| RAM+ERL (n = 26) | PBO+ERL (n = 30) | Treatment effect/estimate | RAM+ERL (n = 224) | PBO+ERL (n = 225) | Treatment effect/estimate | |
| ORR (CR+PR), n (%) [95% CI] | 24 (92) [82–100] | 18 (60) [43–78] | 171 (76) [71–82] | 168 (75) [69–80] | ||
| DCR (CR+PR+SD), n (%) [95% CI] | 26 (100) [100–100] | 28 (93) [84–100] | 213 (95) [92–98] | 215 (96) [93–98] | ||
| Taiwanese subgroup | Overall RELAY ITT populationa | |||||
|---|---|---|---|---|---|---|
| RAM+ERL (n = 24) | PBO+ERL (n = 18) | Treatment effect/estimate | RAM+ERL (n = 171) | PBO+ERL (n = 168) | Treatment effect/estimate | |
| DoR | ||||||
| Median, mo [95% CI] | 18.2 [9.7–26.2] | 12.7 [9.7–16.6] | 5.5 | 18.0 [13.9–19.8] | 11.1 [9.7–12.3] | 6.9 |
| HR [95% CI] | 0.61 [0.28–1.33] | 0.62b [0.48–0.81] | ||||
| Interim OS | ||||||
| Censored | 24 (92) | 28 (93) | NR | NR | ||
| Median, mo | NR | NR | NR | NR | ||
| HR [95% CI] | 1.16c [0.16–8.25] | 0.83b [0.53–1.30] | ||||
| PFS2 | ||||||
| Censored | 24 (92) | 28 (93) | NR | NR | ||
| Median, mo | NR | NR | NR | NR | ||
| HR [95% CI] | 1.16c [0.16–8.25] | 0.69b [0.49–0.97] | ||||
aData published in Nakagawa et al. 2019 [20]
bStratified according to randomisation strata (EGFR mutation type, gender, region, and EGFR testing method). Note: Taiwanese population used an unstratified HR
cOS death events only were recorded in the PFS2 analysis
CI confidence interval, DCR disease control rate, DoR duration of response, EGFR epidermal growth factor receptor, ERL erlotinib, HR hazard ratio, ITT intention to treat, mo months, NR not reported, ORR objective response rate, OS overall survival, PBO placebo, PFS progression-free survival, RAM ramucirumab