Table 2.
Summary of efficacy endpoints (per IRC; Lugano criteria) for patients with LBCL (N = 157).
| Endpoint | LBCL (N = 157) |
|---|---|
| Best overall response | |
| Overall response, No. (%) [95% CI]a | 99 (63.1) [55.0–70.6] |
| CR | 63 (40.1) [32.4–48.2] |
| PR | 36 (22.9) [16.6–30.3] |
| SD, No. (%) | 5 (3.2) |
| PD, No. (%) | 37 (23.6) |
| Nonevaluable,b No. (%) | 16 (10.2) |
| DOR,c months, median (range) [95% CI] | 17.3 (0.0+ to 27.8+) [9.7–26.5] |
| DOR in complete responders,c % (95% CI) | |
| Estimated pts remaining in response at 12 mo | 85.7 (73.4–92.6) |
| Estimated pts remaining in response at 24 mo | 64.4 (47.1–77.2) |
| Duration of CR,c % (95% CI) | |
| Estimated pts with CR remaining in CR at 12 mo | 79.2 (65.5–87.9) |
| Estimated pts with CR remaining in CR at 24 mo | 64.2 (47.5–76.8) |
| Time to response, months, median (range) | 1.4 (1.0–8.4) |
| Time to CR, months, median (range) | 2.6 (1.2–23.2) |
| PFS,c months, median (range) [95% CI] | 4.4 (0.0+ to 29.0+) [3.0–8.8] |
| PFS in the overall population,c % (95% CI) | |
| Estimated PFS rate at 12 mo | 39.9 (31.8–47.8) |
| Estimated PFS rate at 24 mo | 27.8 (20.0–36.2) |
| PFS in complete responders,c % (95% CI) | |
| Estimated PFS rate at 12 mo | 87.6 (75.6–93.9) |
| Estimated PFS rate at 24 mo | 65.1 (48.4–77.6) |
| PFS in MRD-negative patients,c % (95% CI) | |
| Estimated PFS rate at 12 mo | 84.3 (71.0–91.8) |
| Estimated PFS rate at 24 mo | 61.6 (43.6–75.3) |
| OS,c months, median (range) [95% CI] | 18.5 (0.3 to 32.7+) [11.7–27.7] |
| OS in the overall population,c % (95% CI) | |
| Estimated OS rate at 12 mo | 58.0 (49.7–65.4) |
| Estimated OS rate at 24 mo | 44.6 (36.4–52.4) |
| OS in complete responders,c % (95% CI) | |
| Estimated OS rate at 12 mo | 95.1 (85.5–98.4) |
| Estimated OS rate at 24 mo | 78.2 (65.4–86.7) |
| OS in MRD-negative patients,c % (95% CI) | |
| Estimated OS rate at 12 mo | 94.4 (83.8–98.2) |
| Estimated OS rate at 24 mo | 77.7 (64.1–86.7) |
The + sign indicates censored value. Median follow-up was 25.1 mo (95% CI, 24.0–26.0).
CI confidence interval, CR complete response, DOR duration of response, IRC Independent Review Committee, LBCL large B-cell lymphoma, MRD minimal residual disease, OS overall survival, PD progressive disease, PFS progression-free survival, PR partial response, pts patients, SD stable disease.
aCalculated based on the Clopper–Pearson method.
bOf 16 nonevaluable patients, 14 had no response assessment before discontinuation, 1 patient had a response assessment after new anticancer therapy was initiated and was censored, and 1 patient had no evidence of disease at baseline and remained on treatment as of the data cutoff.
cOn the basis of Kaplan–Meier estimate.