Comparison of clinical outcomes between SCHOLAR-5 and ZUMA-5
| . | SCHOLAR-5 (n = 85)* . | ZUMA-5 (n = 86) . | Treatment effect . |
|---|---|---|---|
| Time-to-event outcomes | Median months (95% CI) | Median months (95% CI) | Hazard ratio (95% CI) |
| OS | 59.8 (21.9-NE) | NR (31.6, NE) | 0.42 (0.21, 0.83) |
| PFS | 12.7 (6.2, 14.7) | NR (23.5, NE) | 0.30 (0.18, 0.49) |
| Time to next treatment | 23.4 (9.5, NE) | NR (NE, NE) | 0.54 (0.32-0.89) |
| Response outcomes | Responders (%) | Responders (%) | Odds ratio (95% CI) |
| ORR | 42 (49.9%) | 81 (94.2%) | OR: 16.2 (5.6, 46.9) |
| CR | 25 (29.9%)* | 68 (79.1%)† | OR: 8.9 (4.3, 18.3) |
| . | SCHOLAR-5 (n = 85)* . | ZUMA-5 (n = 86) . | Treatment effect . |
|---|---|---|---|
| Time-to-event outcomes | Median months (95% CI) | Median months (95% CI) | Hazard ratio (95% CI) |
| OS | 59.8 (21.9-NE) | NR (31.6, NE) | 0.42 (0.21, 0.83) |
| PFS | 12.7 (6.2, 14.7) | NR (23.5, NE) | 0.30 (0.18, 0.49) |
| Time to next treatment | 23.4 (9.5, NE) | NR (NE, NE) | 0.54 (0.32-0.89) |
| Response outcomes | Responders (%) | Responders (%) | Odds ratio (95% CI) |
| ORR | 42 (49.9%) | 81 (94.2%) | OR: 16.2 (5.6, 46.9) |
| CR | 25 (29.9%)* | 68 (79.1%)† | OR: 8.9 (4.3, 18.3) |
Note that rounding of patients after classifying as responders or nonresponders in the SCHOLAR-5 weighted sample may lead to a small variability in total sample size.
SCHOLAR-5 sample size for PFS was 56.
Response assessments includes CT-based and PET-based scans with limited confirmatory bone marrow biopsies. Thirteen patients with imaging CRs did not receive a confirmatory bone marrow biopsy.