Table 2. Progression-free survival and response rates by ASCT status in ASPIRE and ENDEAVOR.
|
ASPIRE |
ENDEAVOR |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Prior ASCT |
1R1T |
No prior ASCT |
Prior ASCT |
1R1T |
No prior ASCT |
|||||||
| KRd (n=217) | Rd (n=229) | KRd (n=88) | Rd (n=78) | KRd (n=179) | Rd (n=167) | Kd (n=266) | Vd (n=272) | Kd (n=123) | Vd (n =141) | Kd (n=198) | Vd (n=193) | |
| Median PFS | ||||||||||||
| Months (95% CI) | 26.3 (23.1–32.3) | 17.8 (14.5–22.2) | 29.7 (21.3–38.9) | 17.8 (12.9–26.0) | 26.4 (20.5–31.4) | 16.6 (13.9–21.7) | NE (15.6–NE) | 10.2 (8.5–12.2) | NE (16.8–NE) | 11.2 (8.5–15.1) | 17.7 (14.1–NE) | 8.5 (6.5–10.2) |
| HR (95% CI) | 0.68 (0.53–0.87) | 0.70 (0.46–1.07) | 0.76 (0.57–1.01) | 0.61 (0.47–0.79) | 0.46 (0.30–0.69) | 0.43 (0.32–0.59) | ||||||
| P-value (one-sided) | 0.0012 | 0.0471 | 0.0294 | <0.0001 | <0.0001 | <0.0001 | ||||||
| 1-year PFS rate (95% CI) | 79.2 (73.1–84.1) | 63.0 (55.9–69.2) | 78.9 (68.6–86.2) | 64.5 (52.0–74.5) | 73.8 (66.4–79.8) | 61.8 (53.6–69.0) | 61.8 (55.1–67.8) | 46.0 (38.9–52.9) | 70.7 (60.6–78.6) | 48.4 (38.2–57.8) | 63.9 (55.9–70.9) | 35.4 (27.4–43.6) |
| 2-year PFS rate (95% CI) | 56.0 (48.9–62.6) | 40.5(33.3–47.5) | 57.6 (46.1–67.5) | 41.4 (29.3–53.1) | 53.4 (45.3–60.8) | 39.4 (31.5–47.2) | 53.0 (44.2–61.0) | 25.9 (16.7–36.0) | 59.3 (44.8–71.1) | NE (NE–NE) | 32.0 (13.2–52.7) | 17.1 (8.1–29.0) |
| Overall response | ||||||||||||
| CR or better, n (%) | 72 (33.2) | 25 (10.9) | 28 (31.8) | 8 (10.3) | 54 (30.2) | 12 (7.2) | 38 (14.3) | 20 (7.4) | 18 (14.6) | 13 (9.2) | 20 (10.1) | 9 (4.7) |
| VGPR or better, n (%) | 162 (74.7) | 96 (41.9) | 69 (78.4) | 37 (47.4) | 115 (64.2) | 64 (38.3) | 134 (50.4) | 90 (33.1) | 76 (61.8) | 52 (36.9) | 118 (59.6) | 43 (22.3) |
| ORR, % (95% CI) | 90.3 (85.6–93.9) | 65.5 (59.0–71.6) | 89.8 (81.5–95.2) | 69.2 (57.8–79.2) | 83.2 (76.9–88.4) | 68.3 (60.6–75.2) | 73.3 (67.6–78.5) | 66.9 (61.0–72.5) | 83.7 (76.0–89.8) | 68.1 (59.7–75.7) | 81.8 (75.7–86.9) | 56.5 (49.2–63.6) |
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.