Table 5.
Activity and efficacy of atezolizuamb as emerged from the multiarm Phase II trials FIR and BIRCH
| Trial
|
FIR15
|
BIRCH17
|
||||
|---|---|---|---|---|---|---|
| Cohorts | 1 | 2 | 3 | 1 | 2 | 3 |
| 1st line | ≥2nd line, no BM | ≥2nd line, treated BM | 1st line | 2nd line | ≥3rd line | |
| Objective response rate (ORR), % | ||||||
| All (TC2/3 or IC2/3) | 29% | 19% | 23% | 26% | 20% | 20% |
| pts | 9/31 | 17/92 | 3/13 | 36/139 | 53/268 | 50/252 |
| TC3 or IC3 | 43% | 26% | 25% | 35% | 26% | 31% |
| pts | 3/7 | 9/38 | 2/8 | 23/65 | 32/112 | 36/115 |
| TC2 or IC2 | NA | NA | NA | 18% | 14% | 10% |
| pts | 13/74 | 20/146 | 14/136 | |||
| Overall survival (OS), months | ||||||
| All (TC2/3 or IC2/3) | 14.4 | 9.3 | 6.8 | 24 | 15.5 | 13.2 |
| pts | 31 | 93 | 13 | 138 | 269 | 252 |
| TC3 or IC3 | 15.8 | 22.2 | 7.0 | 26.9 | 16.6 | 17.5 |
| pts | 7%–23% | 38%–41% | 8%–62% | 65%–47% | 122%–46% | 115%–46% |
| TC2 or IC2 | NA | NA | NA | 23.5 | 15.5 | 11.0 |
| pts | 73%–53% | 146%–54% | 136%–54% | |||
Notes: ORRs are reported according to conventional RECIST criteria version 1.1, nevertheless, ORRs measured in line with modified Recist (the primary objective of FIR trial) were higher.
Abbreviations: BM, brain metastases; NA, not available; pts, patients; TC, tumor cell; IC, immune cell.