Table 1 Efficacy outcomes
From: A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma
Per-protocol dataset | Full analysis dataset | |||||
|---|---|---|---|---|---|---|
H-CHOP (n = 188) | R-CHOP (n = 194) | P value | H-CHOP (n = 199) | R-CHOP (n = 203) | P value | |
Best overall response rate | 177 (94·1) | 180 (92·8) | 0·608 | 184 (92·5) | 187 (92·1) | 0·839 |
Complete response | 88 (46·8) | 101 (52·1) | 0·231 | 90 (45·2) | 104 (51·2) | 0·190 |
Partial response | 89 (47·3) | 79 (40·7) | 94 (47·2) | 83 (40·9) | ||
Stable disease | 8 (4·3) | 13 (6·7) | 11 (5·5) | 15 (7·4) | ||
Disease progression | 2 (1·1) | 1 (0·5) | 2 (1·0) | 1 (0·5) | ||
No evidence of disease | 1 (0·5) | 0 | 2 (1·0) | 0 | ||
Duration of response | ||||||
Patients experiencing events | 25 (13·8) | 21 (11·5) | 0·424 | 26 (13·7) | 21 (11·1) | 0·355 |
Patients censored | 156 (86·2) | 161 (88·5) | 164 (86·3) | 168 (88·9) | ||
Event-free survival | ||||||
Patients experiencing events | 80 (42·6) | 67 (34·5) | 0·125 | 88 (44·2) | 71 (35·0) | 0·087 |
Patients censored | 108 (57·4) | 127 (65·5) | 111 (55·8) | 132 (65·0) | ||
1-year event-free survival rate | 55·4 (47·9, 63·0) | 64·5 (57·6, 71·4) | 53·7 (46·4, 61·0) | 63·4 (56·6, 70·2) | ||
Progression-free survival | ||||||
Patients experiencing events | 31 (16·5) | 29 (14·9) | 0·534 | 33 (16·6) | 30 (14·8) | 0·473 |
Patients censored | 157 (83·5) | 165 (85·1) | 166 (83·4) | 173 (85·2) | ||
1-year progression-free survival rate | 75·0 (66·5, 83·6) | 80·1 (73·5, 86·7) | 74·1 (65·6, 82·7) | 79·7 (73·1, 86·3) | ||
Overall survival | ||||||
Patient deaths | 15 (8·0) | 13 (6·7) | 0·661 | 16 (8·0) | 14 (6·9) | 0·701 |
Patients censored | 173 (92·0) | 181 (93·3) | 183 (92·0) | 189 (93·1) | ||
1-year overall survival rate | 91·8 (87·8, 95·8) | 92·4 (88·3, 96·6) | 91·6 (87·6, 95·5) | 92·1 (88·0, 96·3) | ||
Disease-free survival | ||||||
Patients experiencing events | 27 (14·4) | 24 (12·4) | 0·462 | 28 (14·1) | 25 (12·3) | 0·477 |
Patients censored | 161 (85·6) | 170 (87·6) | 171 (85·9) | 178 (87·7) | ||
1-year disease-free survival rate | 77·4 (68·9, 85·9) | 83·0 (76·7, 89·3) | 76·9 (68·4, 85·4) | 82·6 (76·2, 88·9) | ||