Table 2.
Results of Phase II/III trials for NSCLC.
| Number of patients (N = 100%) | ORR % | Median PFS, months | OS, months | Median DOR, months | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BIRCH19 | 1L | 139 | 24 | 7.3 | 20.1 | 13.1 | ||||||
| 2L | 268 | 19 | 2.8 | 15.5 | 14.1 | |||||||
| 3L+ | 252 | 19 | 3.0 | 13.2 | 14.1 | |||||||
| FIR20 | 1L | 31 | 29 | 39 | NR | NR | ||||||
| 2L+ | 71 | 17 | 35 | NR | 12 | |||||||
| 2Lb+ | 12 | 12 | NE | NR | NR | |||||||
| OAK22 |
|
Atz |
Dox |
Atz |
Dox |
Atz |
Dox |
Atz |
Dox |
Atz |
Dox |
|
| ALL | 425 | 425 | 14 | 13 | 2.8 | 4.0 | 13.8 | 9.6 | 16.3 | 6.2 | ||
| IC-TC 0 | 180 | 199 | 7.8 | 10.6 | 2.6 | 4.0 | 12.6 | 8.9 | NE | 6.2 | ||
| IC-TC 1/2/3 | 241 | 222 | 17.8 | 16.2 | 2.8 | 4.1 | 15.7 | 10.3 | 16.0 | 6.2 | ||
| IC-TC 2/3 | 129 | 136 | 22.5 | 12.5 | 3.6 | 4.1 | 16.3 | 10.8 | 14.7 | 9.2 | ||
| IC-TC 3 | 72 | 65 | 30.6 | 10.8 | 3.3 | 4.2 | 20.5 | 8.9 | 12.5 | 6.3 | ||
| POPLAR17 |
|
Atz (144) |
Dox (143) |
Atz |
Dox |
Atz |
Dox |
Atz |
Dox |
Atz |
Dox |
|
| ALL | 287 | 14.6 | 14.7 | 2.7 | 3.0 | 12.6 | 9.7 | 14.3 | 7.2 | |||
| IC-TC 0 | 92 | 7.8 | 9.8 | 1.7 | 4.1 | 9.7 | 9.7 | NR | NR | |||
| IC-TC 1/2/3 | 195 | 18.3 | 16.7 | 2.8 | 3.0 | 15.5 | 9.2 | NR | NR | |||
| IC-TC 2/3 | 105 | 22.0 | 14.5 | 3.4 | 2.8 | 15.1 | 7.4 | NR | NR | |||
| IC-TC 3 | 47 | 37.5 | 13.0 | 7.8 | 3.9 | 15.5 | 11.1 | NR | NR | |||
NR- Not reported; NE- Not evaluable; Atz- Atezolizumab; Dox- Docetaxel; ORR –Overall response rate; PFS- Progression free survival; OS- Overall survival; DOR- Duration of response; L- Line of treatment; b- treated asymptomatic brain metastases; IC –Immune cell; TC- Tumor cell.