Analysis of response with zanubrutinib treatment, as assessed by Independent Review Committee for MZL and by investigators for FL, based on the Lugano classification
| Response . | R/R MZL (N=20) . | R/R FL (N=33) . |
|---|---|---|
| Median (range) study follow-up time, months | 35.2 (8.3–59.2) | 32.8 (1.8–58.7) |
| Best overall response, n (%) | ||
| ORR, n (%) (95% CI) | 16 (80) (56.3–94.3) | 12 (36.4) (20.4–54.9) |
| Complete response, n (%) | 4 (20) | 6 (18.2) |
| Partial response, n (%) | 12 (60) | 6 (18.2) |
| Stable disease, n (%) | 2 (10) | 13 (39.4) |
| Progressive disease, n (%) | 1 (5) | 5 (15.2) |
| Not evaluable, n (%)* | 1 (5) | 0 |
| Discontinued study prior to first assessment | 0 | 3 (9.1) |
| Median (range) TTR (≥PR), months | 2.8 (2.6–23.1) | 2.7 (1.6–5.6) |
| Best response by subtype, n (%) | ||
| Extranodal (MALT), ORR, n (%) | 8/9 (88.9) | |
| Nodal, ORR, n (%) | 5/5 (100) | |
| Splenic, ORR, n (%) | 3/6 (50) | |
| Median and event-free rate | ||
| Median DOR, months (95% CI) | NE (8.4–NE) | NE (8.3–NE) |
| 6-month DOR, % (95% CI) | 87.5 (58.6–96.7) | 100 (NE–NE) |
| 12-month DOR, % (95% CI) | 71.6 (40.3–88.4) | 74.1 (39.1–90.9) |
| 24-month DOR, % (95% CI) | 71.6 (40.3–88.4) | 64.8 (31–85.2) |
| 36-month DOR, % (95% CI) | 71.6 (40.3–88.4) | 64.8 (31–85.2) |
| Median PFS, months (95% CI) | NE (20.3–NE) | 10.4 (7.7–22.9) |
| 6-month PFS, % (95% CI) | 90 (65.6–97.4) | 70 (50.2–83.1) |
| 12-month PFS, % (95% CI) | 84 (57.9–94.6) | 38.2 (20.9–55.3) |
| 24-month PFS, % (95% CI) | 72 (45–87.4) | 30.1 (14.4–47.5) |
| 36-month PFS, % (95% CI) | 72 (45–87.4) | 25.8 (11.2–43.2) |
| Median OS, months (95% CI) | NE (NE–NE) | NE (37.3–NE) |
| 6-month OS, % (95% CI) | 100.0 (NE–NE) | 90.3 (72.7–96.8) |
| 12-month OS, % (95% CI) | 100.0 (NE–NE) | 86.8 (68.5–94.8) |
| 24-month OS, % (95% CI) | 83.9 (59.7–94.5) | 76.1 (56.1–87.9) |
| 36-month OS, % (95% CI) | 83.9 (59.7–94.5) | 76.1 (56.1–87.9) |
| Response . | R/R MZL (N=20) . | R/R FL (N=33) . |
|---|---|---|
| Median (range) study follow-up time, months | 35.2 (8.3–59.2) | 32.8 (1.8–58.7) |
| Best overall response, n (%) | ||
| ORR, n (%) (95% CI) | 16 (80) (56.3–94.3) | 12 (36.4) (20.4–54.9) |
| Complete response, n (%) | 4 (20) | 6 (18.2) |
| Partial response, n (%) | 12 (60) | 6 (18.2) |
| Stable disease, n (%) | 2 (10) | 13 (39.4) |
| Progressive disease, n (%) | 1 (5) | 5 (15.2) |
| Not evaluable, n (%)* | 1 (5) | 0 |
| Discontinued study prior to first assessment | 0 | 3 (9.1) |
| Median (range) TTR (≥PR), months | 2.8 (2.6–23.1) | 2.7 (1.6–5.6) |
| Best response by subtype, n (%) | ||
| Extranodal (MALT), ORR, n (%) | 8/9 (88.9) | |
| Nodal, ORR, n (%) | 5/5 (100) | |
| Splenic, ORR, n (%) | 3/6 (50) | |
| Median and event-free rate | ||
| Median DOR, months (95% CI) | NE (8.4–NE) | NE (8.3–NE) |
| 6-month DOR, % (95% CI) | 87.5 (58.6–96.7) | 100 (NE–NE) |
| 12-month DOR, % (95% CI) | 71.6 (40.3–88.4) | 74.1 (39.1–90.9) |
| 24-month DOR, % (95% CI) | 71.6 (40.3–88.4) | 64.8 (31–85.2) |
| 36-month DOR, % (95% CI) | 71.6 (40.3–88.4) | 64.8 (31–85.2) |
| Median PFS, months (95% CI) | NE (20.3–NE) | 10.4 (7.7–22.9) |
| 6-month PFS, % (95% CI) | 90 (65.6–97.4) | 70 (50.2–83.1) |
| 12-month PFS, % (95% CI) | 84 (57.9–94.6) | 38.2 (20.9–55.3) |
| 24-month PFS, % (95% CI) | 72 (45–87.4) | 30.1 (14.4–47.5) |
| 36-month PFS, % (95% CI) | 72 (45–87.4) | 25.8 (11.2–43.2) |
| Median OS, months (95% CI) | NE (NE–NE) | NE (37.3–NE) |
| 6-month OS, % (95% CI) | 100.0 (NE–NE) | 90.3 (72.7–96.8) |
| 12-month OS, % (95% CI) | 100.0 (NE–NE) | 86.8 (68.5–94.8) |
| 24-month OS, % (95% CI) | 83.9 (59.7–94.5) | 76.1 (56.1–87.9) |
| 36-month OS, % (95% CI) | 83.9 (59.7–94.5) | 76.1 (56.1–87.9) |
Percentages are based on the number of patients who received ≥1 dose of zanubrutinib. Efficacy analysis set: 2-sided Clopper-Pearson 95% CI. Medians were estimated by Kaplan–Meier method with 95% CIs estimated using the Brookmeyer and Crowley method. Event-free rates were estimated by Kaplan–Meier method with 95% CIs estimated using the Greenwood formula.
For 1 patient, the IRC reported no measurable disease, and only splenomegaly was present. Per IRC charter, if there was no measurable disease, an assessment of “not evaluable” was reported.
CI indicates confidence interval; DOR, duration of response; FL, follicular lymphoma; MALT, mucosa-associated lymphoid tissue, MZL, marginal zone lymphoma; NE, not estimable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; R/R, relapsed/refractory; TTR, time to response; +, censored.