Table 2.

IRC-assessed efficacy outcomes

R/RTNOverall
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/RTNOverall
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.