Table 2. Summary of efficacy.
| Efficacy endpoint | Linsitinib/erlotinib (n=102) | Placebo/erlotinib (n=103) | HR (95% CI) | P-value |
|---|---|---|---|---|
| Progression-free survival | ||||
| Number of events, n (%) | 74 (72.5) | 75 (72.8) | 1.09 | 0.601 |
| Median, days (95% CI) | 125 (88–167) | 129 (88–158) | (0.788–1.507) | |
| Overall survival | ||||
| Number of events, n (%) | 44 (43.1) | 38 (36.9) | 1.20 | 0.409 |
| Median, days (95% CI) | 381 (316–672) | 421 (367–NR) | (0.777, 1.853) | |
| Best overall response, n (%) | NA | NA | ||
| Complete response | 1 (1.0) | 0 (0) | ||
| Partial response | 15 (14.7) | 12 (11.7) | ||
| Stable disease | 53 (52.0) | 58 (56.3) | ||
| Progressive disease | 27 (26.5) | 26 (25.2) | ||
| Not evaluated | 6 (5.9) | 7 (6.8) | ||
| Disease control rate,a n (%) | 69 (67.7) | 70 (68.0) | NA | NA |
| 95% CI | (57.66–76.58) | (58.04–76.82) | ||
| Objective response rate,b n (%) | 16 (15.7) | 12 (11.7) | NA | NA |
| 95% CI | (9.24–24.22) | (6.17–19.47) | ||
| Response upgrade rate,c n (%) | 11 (10.78) | 9 (8.74) | NA | NA |
| 95% CI | (5.51–18.48) | (4.07–5.94) |
Abbreviations: CI=confidence interval; HR=hazard ratio; NA=not applicable.
a
Disease control rate=complete response+partial response+stable disease.
b
Overall response rate=complete response+partial response.
c
Response upgrade rate=proportion of patients with a response upgrade in comparison to their best response at the start of the study.