TABLE 2.
Efficacy results based on central review for relapsed/refractory MCL patients treated with lenalidomide
| Efficacy parameter | NHL-002/NHL-003a (n = 72) | MCL-001 (n = 134) | Post-bortezomib (n = 157) | All MCL patients (N = 206) |
|---|---|---|---|---|
| ORRb, n (%) | 28 (39) | 40 (30) | 48 (31) | 68 (33) |
| CR/CRu | 10 (14) | 12 (9) | 14 (9) | 22 (11) |
| PR | 18 (25) | 28 (21) | 34 (22) | 46 (22) |
| SD, n (%) | 27 (38) | 38 (28) | 48 (31) | 65 (32) |
| PD, n (%) | 16 (22) | 34 (25) | 39 (25) | 50 (24) |
| Median TTR, months (range) | 1.9 (1.6–24.2) | 3.5 (1.7–15.9) | 2.3 (1.6–15.9) | 2.2 (1.6–24.2) |
| CR/CRu patients | 1.9 (1.6–20.9) | 2.2 (1.8–5.5) | 2.1 (1.6–5.5) | 2.0 (1.6–20.9) |
| Median DOR, months (95% CI) | 16.3 (7.1–NR) | 16.6 (10.4–29.8) | 16.6 (8.9–28.1) | 16.6 (11.1–29.8) |
| CR/CRu patients | NR (NR–NR) | 24.4 (5.1–NR) | 24.4 (11.0–NR) | 28.1 (11.0–NR) |
| PR patients | 8.0 (4.1–32.4) | 14.8 (7.7–29.8) | 11.1 (5.8–26.7) | 11.1 (6.5–26.7) |
| Median PFS, months (95% CI) | 5.8 (3.7–13.5) | 4.0 (3.7–7.2) | 4.5 (3.7–7.2) | 5.5 (3.7–7.4) |
| Median OS, months (95% CI) | NR (NR–NR) | 19.5 (13.7–25.6) | 21.5 (13.7–28.4) | 24.4 (19.0–30.0) |
Abbreviations: CR, complete response; CRu, unconfirmed complete response; DOR, duration of response; NR, not reached; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; TTR, time to response. NHL-002/003 data were locked at June 23, 2008 and April 27, 2011, respectively; data cut-off for MCL-001 was April 06, 2016.
a
Includes data from investigator assessment in NHL-002.
b
Reflects best response rates. Response data for 23 patients were missing.