Table 3. Progression-free survival and response by time to relapse in ASPIRE and ENDEAVOR.
ASPIRE (1R1T subgroup) |
ENDEAVOR (1R1T subgroup) |
|||||||
---|---|---|---|---|---|---|---|---|
Early relapsers |
Late relapsers |
Early relapsers |
Late relapsers |
|||||
KRd (n=19) | Rd (n=19) | KRd (n=69) | Rd (n=59) | Kd (n=23) | Vd (n=28) | Kd (n=99) | Vd (n=110) | |
PFS | ||||||||
Median PFS, months (95% CI) | 15.2 (5.1–24.1) | 9.3 (3.9–16.1) | 33.5 (25.9–38.9) | 24.3 (15.0–NE) | NE (7.1–NE) | 8.0 (2.8–12.1) | NE (15.6–NE) | 11.2 (8.8–NE) |
HR, KRd/Rd or Kd/Vd (95% CI) | 0.751 (0.353–1.599) | 0.718 (0.432–1.195) | 0.357 (0.153–0.832) | 0.479 (0.297–0.771) | ||||
P-value (one-sided) | 0.2279 | 0.0996 | 0.0065 | 0.0010 | ||||
Overall response | ||||||||
CR or better, n (%) | 1 (5.3) | 0 | 27 (39.1) | 8 (13.6) | 0 | 0 | 18 (18.2) | 13 (11.8) |
VGPR or better, n (%) | 13 (68.4) | 7 (36.8) | 56 (81.2) | 30 (50.8) | 12 (52.2) | 5 (17.9) | 63 (63.6) | 45 (40.9) |
ORR (95% CI) | 78.9 (54.4–93.9) | 57.9 (33.5–79.7) | 92.8 (83.9–97.6) | 72.9 (59.7–83.6) | 87.0 (66.4–97.2) | 50.0 (30.6–69.4) | 82.8 (73.9–89.7) | 71.8 (62.4–80.0) |
Abbreviations: 1R1T, first relapse after frontline ASCT; ASCT, autologous stem cell transplantation; CI, confidence interval; CR, complete response; HR, hazard ratio; Kd, carfilzomib+dexamethasone; KRd, carfilzomib+lenalidomide+dexamethasone; NE, not estimable; ORR, overall response rate; PFS, progression-free survival; Rd, lenalidomide+dexamethasone; Vd, bortezomib+dexamethasone; VGPR, very good partial response. Includes patients who enrolled in study at first relapse post-ASCT. Early relapsers refers to patients relapsing <12 months post-ASCT. Late relapsers refers to patients relapsing ⩾12 months post-ASCT.