Table 2 Baseline characteristics relevant to lenalidomide and daratumumab refractoriness in phase 2 and 3 RRMM clinical trials.
OPTIMISMM [45] | IC 2013-05 [61] | APOLLO [95] | MM-014 Arm B [58] | CASTOR [50] | CANDOR [96] | ICARIA-MM [59] | |||
|---|---|---|---|---|---|---|---|---|---|
Triplet regimen studied | POM/DEX + BORT | POM/DEX + CFZ | POM/DEX + Cy | DARA + POM/DEX | DARA + POM/DEX | DARA + BORT/DEX | DARA + CFZ/DEX | ISA + POM/DEX | ISA + CFZ/DEX |
Phase | 3 | 2 | 2 | 3 | 2 | 3 | 3 | 3 | 3 |
Clinical trial identifier | NCT01734928 | NTR5349 | NCT02244125 | NCT03180736 | NCT01946477 | NCT02136134 | NCT03158688 | NCT02990338 | NCT03275285 |
Patients, n | 281 | 60 | 100 | 151 | 112 | 498 | 466 | 154 | 302 |
Prior lines of therapy, median (range), n | 2 (1–2) | – | 1 | 2 (1–5) | 1 (1–2) | 2 (1–10) | 2 (1–2) | 3 (2–4) | (1–≥3) |
Exposed to prior LEN, % | 100 | 100 | 100 | 100 | 100 (last line) | 76 (IMiD) | 42 | 100 | 78 (IMiD) |
Refractory to LEN, % Refractory to LEN + PI, % | 71 – | – – | 0 – | 79 42 | 75 – | 32.9 (IMiD) – | 33 – | 94 72 (LEN in last line: 60) | – – |
Refractory to LEN-based maintenance, % | – | 95 | – | – | – | – | – | – | – |
Exposed to prior daratumumab, % | – | – | – | – | 0 | – | <1% (anti-CD38 antibody) | n = 1 | – |
Refractory to daratumumab, % | – | – | – | 0 | 0 | 0 | – | – | 0 |
Exposed to prior PI, % | 75 | – | – | 100 | 79.5 | – | – | 100 | 90 |
BORT | 72 | – | 100 | – | 78 | 65.5 | 90 | – | – |
CFZ | 3 | – | – | – | 10 | – | – | – | – |
IXA | 3 | – | – | – | 4 | – | – | – | – |
Refractory to PI, % | 13 | – | – | 47 | – | – | – | 77 | – |
BORT | 9 | 100 | – | – | – | 0 | 29 | – | – |
CFZ | – | – | – | – | – | 0 | |||
Prior ASCT, % | 57 | 67 | 50 | 60 | 70 | 61 | – | 54 | – |
Prior-treatment subgroup analyses | LEN-refr; 1 prior therapy; LEN-refr + 1 prior therapy | – | – | LEN-refr | Prior line of therapy (1, 2); dose of prior LEN (≤10 mg, >10 mg); LEN-rel, LEN-refr; prior LEN + PI; ASCT | Prior line of therapy (1, 2, 3); prior BORT | Prior line of therapy (1, ≥2); prior PI; prior LEN exposure; refr to LEN; refr to BORT or IXA; prior immunomodulatory drug exp or refr | Prior line of therapy (2–3; >3); LEN-refr; PI-ref; LEN + PI refr; LEN (last line)-refr; PI (last line)-refr; prior ASCT | Prior line of therapy |
