Table 2.
Treatment responses per IMWG-URC in patients with RRMM treated with once-weekly KRd56 vs twice-weekly KRd27 over the study duration
| Once-weekly KRd56 (N = 228) | Twice-weekly KRd27 (N = 226) | |
|---|---|---|
| ORR, % (95% CI) | 82.5 (76.9-87.2) | 86.3 (81.1-90.5) |
| 1-sided P∗ | 0.0666 | |
| Risk ratio (95% CI) | 0.954 (0.882-1.032) | |
| Best overall response, n (%) | ||
| Stringent CR | 46 (20.2) | 30 (13.3) |
| CR | 61 (26.8) | 52 (23.0) |
| VGPR | 59 (25.9) | 80 (35.4) |
| PR | 22 (9.6) | 33 (14.6) |
| Stable disease or progressive disease | 19 (8.3) | 20 (8.8) |
| Not evaluable | 21† (9.2) | 11‡ (4.9) |
| Median time to response§, mo (range) | 1.0 (1-10) | 1.0 (1-12) |
IMWG-URC, International Myeloma Working Group Uniform Response Criteria; VGPR, very good partial response.
P was calculated via the synthesis approach (US Food and Drug Administration, 2016)17 for noninferiority comparison of ORR between treatment groups.
Seven patients had no postbaseline visit (including 5 deaths in cycle 1; 2 patients ended the study on days 46 and 62, respectively), 7 patients had 1 postbaseline visit, 4 patients had nonmeasurable disease, 1 patient had 2 baseline visits, 1 patient had no postbaseline plasmacytoma assessment, and 1 patient achieved a PR per investigator evaluation.
Four patients had no postbaseline visit (including 1 death each on days 17 and 76), 3 patients had 1 postbaseline visit, and 4 patients had nonmeasurable disease.
Time from the randomization date to the earliest date of confirmation of a PR or better.