Table 2 Efficacy results in full analysis set.

From: QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

 

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)

 
  1. 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.
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