Table 2.
Efficacy results in full analysis set.
| QL1209 n/N (%, 90%) | Reference pertuzumab n/N (%, 90%) | Relative risk | |
|---|---|---|---|
| Assessed by IRC | |||
| tpCR | 109/255 (42.75; 37.65 to 47.84) | 117/259 (45.17; 40.09 to 50.26) | 0.95 (0.80 to 1.11) |
| tpCR according to clinical stage | |||
| Early stage | 69/159 (43.40; 36.93 to 49.86) | 80/165 (48.48; 42.09 to 54.88) | |
| Locally advanced | 40/96 (41.67; 33.39 to 49.94) | 37/94 (39.36; 31.07 to 47.65) | |
| bpCR | 128/256 (50.00; 44.86 to 55.14) | 134/259 (51.74; 46.63 to 56.84) | |
| Assessed by INV | |||
| tpCR | 109/257 (42.41; 37.34 to 47.48) | 120/259 (46.33; 41.24 to 51.43) | 0.92 (0.78 to 1.08) |
| bpCR | 125/257 (48.64; 43.51 to 53.77) | 133/259 (51.35; 46.24 to 56.46) | |
| ORR | 212/257 (82.49; 78.59 to 86.39) | 212/259 (81.85; 77.91 to 85.79) | |
Data are n (%; 90% CI), IRC independent review committee, INV investigator, tpCR total pathological complete response, bpCR breast pathological complete response, ORR objective response rate.