Table 3. Subgroup analysis and biomarker subgroup analysis of PFS.
|
Linsitinib/erlotinib (n=102) |
Placebo/erlotinib (n=103) |
||||||
|---|---|---|---|---|---|---|---|
| N | Events n (%) | Median in days | N | Events n (%) | Median in days | HR, linsitinib vs placebo (95% CI) | |
|
Subgroup analysisa | |||||||
| EGFR mutation status | |||||||
| Wild-type | 85 | 67 (78.8) | 92 | 85 | 70 (82.4) | 106 | 1.10 (0.78–1.54) |
| Activating | 17 | 7 (41.2) | 463 | 18 | 5 (27.8) | 651 | 1.81 (0.52–6.32) |
| Histology | |||||||
| Squamous | 23 | 19 (82.6) | 127 | 26 | 25 (96.2) | 113 | 0.67 (0.36–1.24) |
| Non-squamous | 79 | 55 (69.6) | 125 | 77 | 50 (64.9) | 133 | 1.26 (0.86–1.86) |
| Response to prior platinum-based therapy | |||||||
| Complete/partial response | 28 | 23 (82.1) | 85 | 29 | 22 (75.9) | 133 | 1.32 (0.73–2.40) |
| Stable disease | 74 | 51 (68.9) | 154 | 74 | 53 (71.6) | 127 | 1.02 (0.70–1.51) |
| Cigarette smoking history | |||||||
| Never | 20 | 13 (65.0) | 92 | 20 | 13 (65.0) | 171 | 1.56 (0.71–3.43) |
| Former | 59 | 41 (69.5) | 121 | 60 | 46 (76.7) | 116 | 0.91 (0.60–1.39) |
| Current | 23 | 20 (87.0) | 151 | 23 | 16 (69.6) | 106 | 0.97 (0.50–1.91) |
| Cotinine | |||||||
| Positive | 22 | 17 (77.3) | 125 | 21 | 17 (81.0) | 119 | 1.02 (0.51–2.03) |
| Negative | 72 | 51 (70.8) | 121 | 80 | 57 (71.3) | 129 | 1.07 (0.73–1.57) |
| Sex | |||||||
| Male | 62 | 47 (75.8) | 131 | 66 | 49 (74.2) | 116 | 1.07 (0.71–1.60) |
| Female | 40 | 27 (67.5) | 95 | 37 | 26 (70.3) | 133 | 1.18 (0.69–2.03) |
| Age group (years) | |||||||
| <65 | 57 | 45 (78.9) | 121 | 72 | 57 (79.2) | 109 | 1.03 (0.69–1.52) |
| ⩾65 | 45 | 29 (64.4) | 127 | 31 | 18 (58.1) | 171 | 1.30 (0.72–2.34) |
|
Biomarker subgroup analysisb | |||||||
| KRAS mutation status | |||||||
| Wild-type | 72 | 50 (69.4) | 160 | 74 | 54 (73.0) | 133 | 1.01 (0.69–1.49) |
| Activating | 16 | 13 (81.3) | 128 | 16 | 14 (87.5) | 87 | 0.61 (0.28–1.36) |
| PIK3CA mutation status | |||||||
| Wild-type | 87 | 61 (70.1) | 154 | 84 | 64 (76.2) | 124 | 0.89 (0.63–1.27) |
| Activating | 1 | 1 (100) | 131 | 4 | 2 (50.0) | ND | 3.46 (0.22–55.8) |
| EGFR mutation status | |||||||
| Wild-type | 68 | 53 (77.9) | 121 | 73 | 60 (82.2) | 106 | 1.01 (0.70–1.47) |
| Activating | 22 | 11 (50.0) | 304 | 19 | 9 (47.4) | 340 | 1.28 (0.51–3.20) |
| E-cadherin in EGFR wild-type | |||||||
| ⩾Median | 30 | 25 (83.3) | 83 | 33 | 27 (81.8) | 133 | 1.60 (0.92–2.78) |
| <Median | 28 | 20 (71.4) | 128 | 31 | 26 (83.9) | 82 | 0.52 (0.29–0.94) |
Abbreviations: CI=confidence interval; ND=not determined; EGFR=epidermal growth factor receptor; HR=hazard ratio.
a
Subgroup analysis of the full analysis set, which includes any patient who received at least one dose of linsitinib.
b
Biomarker subgroup analysis of patients who had sufficient tissue/plasma samples for analysis among similar evaluable patients.