Table 2.
Summary of best confirmed response to treatment with ixazomib-Rd and placebo-Rd
| Best confirmed response, n (%) | Ixazomib-Rd (n = 57) | Placebo-Rd (n = 58) | p value (unstratified Cochran–Mantel–Haenszel test) |
|---|---|---|---|
| ORR (≥PR) (95% CI) | 32 (56) (42–69) | 18 (31) (20–45) | 0.007 |
| ≥VGPR rate (95% CI) | 14 (25) (14–38) | 7 (12) (5–23) | 0.084 |
| CR | 3 (5) | 0 | 0.078 |
| PR | 29 (51) | 18 (31) | – |
| VGPR | 11 (19) | 7 (12) | – |
| SD | 17 (30) | 17 (29) | – |
| PD | 6 (11) | 15 (26) | – |
| Not evaluable | 2 (4) | 8 (14) | – |
| n = 32 | n = 18 | ||
| Time to response, median (IQR) | 1.0 (0.9–1.8) | 1.0 (0.9–1.9) | – |
| DOR, median (95% CI) | 7.4 months (6.21–NE) | 5.6 months (2.73–9.46) | – |
| Responders who had not progressed at data cut-off, n (%) | 19 (59) | 7 (39) |
Time to response: time from first documentation of PR or better to first documentation of PD; Duration of response: time from first documentation of partial response or better to first documentation of progression
Abbreviations: CR complete response, DOR duration of response, NE not estimable, ORR overall response rate, PD progressive disease, PR partial response, SD stable disease, VGPR very good partial response