Table 2.
Associations of PD-L1 expression on tumor or immune cells with treatment outcomes
| METEOR (N=306) | CABOSUN (N=110) | Combining two trials | ||||||
|---|---|---|---|---|---|---|---|---|
| All patients (N=416) |
cabozantinib only (N=211) |
|||||||
| Total/ No. of Events |
Median months (95%CI) |
Adjusted* hazard ratio (95%CI) |
Total/ No. of Events |
Median months (95%CI) |
Adjusted* hazard ratio (95%CI) |
Adjusted* hazard ratio (95%CI) |
Adjusted* hazard ratio (95%CI) |
|
| Tumor cells (≥1% cutoff) | ||||||||
| PFS | ||||||||
| PD-L1(−) | 218/126 | 7.2 (5.6-7.5) |
1(reference) | 85/45 | 8.3 (5.4-12.9) |
1(reference) | 1(reference) | 1(reference) |
| PD-L1(+) | 88/60 | 5.3 (3.7-5.6) |
1.19 (0.86-1.63) |
25/20 | 5.5 (2.8-10.1) |
1.26 (0.72-2.23) |
1.21 (0.92-1.61) |
1.28 (0.83-1.99) |
| p-value | 0.027 | 0.301 | 0.051 | 0.419 | 0.173 | 0.265 | ||
| OS | ||||||||
| PD-L1(−) | 218/91 | 21.3 (18.0-NR) |
1(reference) | 85/44 | 28.1 (18.9-NR) |
1(reference) | 1(reference) | 1(reference) |
| PD-L1(+) | 88/52 | 15.1 (10.4-18.8) |
1.37 (0.97-1.94) |
25/18 | 20.8 (12.3-26.6) |
1.46 (0.81-2.65) |
1.39 (1.03-1.87) |
1.63 (1.03-2.60) |
| p-value | 0.003 | 0.078 | 0.047 | 0.209 | 0.034 | 0.038 | ||
| Immune cells (≥1% cutoff) | ||||||||
| PFS | ||||||||
| PD-L1(−) | 122/76 | 7.2 (5.6-7.5) |
1(reference) | 43/27 | 5.8 (4.3-12.9) |
1(reference) | 1(reference) | 1(reference) |
| PD-L1(+) | 179/107 | 5.5 (3.8-5.7) |
1.16 (0.86-1.57) |
67/38 | 8.3 (5.4-12.4) |
0.96 (0.57-1.61) |
1.09 (0.84-1.41) |
1.10 (0.74-1.62) |
| p-value | 0.136 | 0.324 | 0.698 | 0.864 | 0.512 | 0.649 | ||
| OS | ||||||||
| PD-L1(−) | 122/52 | 21.3 (17.3-NR) |
1(reference) | 43/22 | 35.4 (17.5-NR) |
1(reference) | 1(reference) | 1(reference) |
| PD-L1(+) | 179/89 | 18.4 (15.1-22) |
1.15 (0.81-1.62) |
67/40 | 26.0 (16.4-30.3) |
1.46 (0.86-2.50) |
1.24 (0.93-1.65) |
1.45 (0.93-2.26) |
| p-value | 0.101 | 0.443 | 0.237 | 0.165 | 0.145 | 0.103 | ||
PFS: Progression free survival; OS: Overall survival
*
All models were adjusted for treatment, IMDC risk groups and presence of bone metastases. For METEOR and combined analysis, the models were also adjusted for number of previous VEGFR TKI treatment (1 or ≥2 for METEOR, 0, 1, or ≥2 for the combined analysis).