IRC-assessed efficacy outcomes
| . | R/R . | TN . | Overall . | |||
|---|---|---|---|---|---|---|
| Ibrutinib (n = 81) . | Zanubrutinib (n = 83) . | Ibrutinib (n = 18) . | Zanubrutinib (n = 19) . | Ibrutinib (n = 99) . | Zanubrutinib (n = 102) . | |
| Best overall response, n (%) | ||||||
| CR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| VGPR | 16 (20) | 24 (29) | 3 (17) | 5 (26) | 19 (19) | 29 (28) |
| PR | 49 (61) | 41 (49) | 9 (50) | 9 (47) | 58 (59) | 50 (49) |
| MR | 11 (14) | 13 (16) | 4 (22) | 4 (21) | 15 (15) | 17 (17) |
| SD | 2 (3) | 3 (4) | 1 (6) | 0 (0) | 3 (3) | 3 (3) |
| PD | 2 (3) | 1 (1) | 0 (0) | 1 (5) | 2 (2) | 2 (2) |
| Not evaluable* | 1 (1) | 1 (6) | 1 (1) | 0 (0) | 2 (2) | 1 (1) |
| Response rates, % (95% CI)† | ||||||
| VGPR or CR | 20 (12-30) | 29 (20-40) | 17 (4-41) | 26 (9-51) | 19‡ (12-28) | 28 (20-38) |
| P | .12 | NR | .09 | |||
| MRR | 80 (70-88) | 78 (68-87) | 67 (41-87) | 74 (49-91) | 78 (68-86) | 77 (68-85) |
| ORR | 94 (86-98) | 94 (87-98) | 89 (65-99) | 95 (74-100) | 93 (86-97) | 94 (88-98) |
| Duration of CR/VGPR, mo | ||||||
| Median (range) | NE (1, 21+) | NE (0+, 19+) | NE (0+, 3+) | NE (0+, 22+) | NE (0+, 21+) | NE (0+, 22+) |
| 18-Mo event-free rate, % (95% CI)§ | 64 (29-85) | 90 (47-99) | NE (NE, NE) | 100 (NE, NE) | 64 (29-85) | 93 (59-99) |
| Duration of major response, months | ||||||
| Median (range) | NE (0+, 26+) | NE (0+, 25+) | NE (3+, 28+) | NE (0+, 25+) | NE (0+, 28+) | NE (0+, 25+) |
| 18-Mo event-free rate, % (95% CI)§ | 86 (73-93) | 87 (73-94) | 100 (NE, NE) | 80 (39-95) | 88 (77-94) | 85 (72-93) |
| PFS | ||||||
| Median (range), mo | NE (0, 28+) | NE (0+, 28+) | NE (0+, 31+) | NE (1, 31+) | NE (0+, 31+) | NE (0+, 31+) |
| 18-Mo event-free rate, % (95% CI)§ | 82 (71-89) | 86 (74-93) | 94 (63-99) | 78 (52-91) | 84 (75-90) | 85 (75-91) |
| . | R/R . | TN . | Overall . | |||
|---|---|---|---|---|---|---|
| Ibrutinib (n = 81) . | Zanubrutinib (n = 83) . | Ibrutinib (n = 18) . | Zanubrutinib (n = 19) . | Ibrutinib (n = 99) . | Zanubrutinib (n = 102) . | |
| Best overall response, n (%) | ||||||
| CR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| VGPR | 16 (20) | 24 (29) | 3 (17) | 5 (26) | 19 (19) | 29 (28) |
| PR | 49 (61) | 41 (49) | 9 (50) | 9 (47) | 58 (59) | 50 (49) |
| MR | 11 (14) | 13 (16) | 4 (22) | 4 (21) | 15 (15) | 17 (17) |
| SD | 2 (3) | 3 (4) | 1 (6) | 0 (0) | 3 (3) | 3 (3) |
| PD | 2 (3) | 1 (1) | 0 (0) | 1 (5) | 2 (2) | 2 (2) |
| Not evaluable* | 1 (1) | 1 (6) | 1 (1) | 0 (0) | 2 (2) | 1 (1) |
| Response rates, % (95% CI)† | ||||||
| VGPR or CR | 20 (12-30) | 29 (20-40) | 17 (4-41) | 26 (9-51) | 19‡ (12-28) | 28 (20-38) |
| P | .12 | NR | .09 | |||
| MRR | 80 (70-88) | 78 (68-87) | 67 (41-87) | 74 (49-91) | 78 (68-86) | 77 (68-85) |
| ORR | 94 (86-98) | 94 (87-98) | 89 (65-99) | 95 (74-100) | 93 (86-97) | 94 (88-98) |
| Duration of CR/VGPR, mo | ||||||
| Median (range) | NE (1, 21+) | NE (0+, 19+) | NE (0+, 3+) | NE (0+, 22+) | NE (0+, 21+) | NE (0+, 22+) |
| 18-Mo event-free rate, % (95% CI)§ | 64 (29-85) | 90 (47-99) | NE (NE, NE) | 100 (NE, NE) | 64 (29-85) | 93 (59-99) |
| Duration of major response, months | ||||||
| Median (range) | NE (0+, 26+) | NE (0+, 25+) | NE (3+, 28+) | NE (0+, 25+) | NE (0+, 28+) | NE (0+, 25+) |
| 18-Mo event-free rate, % (95% CI)§ | 86 (73-93) | 87 (73-94) | 100 (NE, NE) | 80 (39-95) | 88 (77-94) | 85 (72-93) |
| PFS | ||||||
| Median (range), mo | NE (0, 28+) | NE (0+, 28+) | NE (0+, 31+) | NE (1, 31+) | NE (0+, 31+) | NE (0+, 31+) |
| 18-Mo event-free rate, % (95% CI)§ | 82 (71-89) | 86 (74-93) | 94 (63-99) | 78 (52-91) | 84 (75-90) | 85 (75-91) |
Percentages are based on N, the number of randomized patients.
+, censored observations; MR, minimal response; NE, not estimable; ORR, overall response rate; NR, not reported; PD, progressive disease; SD, stable disease.
NE includes patients with unknown response, disease flare, and study discontinuation prior to first disease assessment.
95% CIs were estimated using the Clopper-Pearson method.
Two R/R ibrutinib-treated patients assessed as having VGPRs by independent review were assigned a best response of PR and MR by their investigators.
Event-free rates were estimated by K-M methodology, with 95% CIs estimated using Greenwood’s formula.