Table 2.
Summary of key Phase 3 clinical trials in RRMM in LEN resistant/refractory patient subgroup.
| Trial | % LEN Refractory | ORR (%) | PFS | OS |
|---|---|---|---|---|
| NIMBUS (MM-003) POM-loDex vs. HiDex |
92 vs. 95 | 30 vs. 9 | 3.9 vs. 1.9 months (HR 0.50, p < 0.001) | 12.7 vs. 8.0 months (HR 0.73, p = 0.0234) |
| STRATUS (MM-010) POM-loDex |
95 | 32.1 | 4.6 months | 11.9 months |
| OPTIMISMM POM-BOR-dex vs. BOR-dex |
69 vs. 71 | 82.2 vs. 50.0 | 11.2 vs. 7.1 months (HR 0.65, p < 0.0001) | Data not yet mature |
| CASTOR DARA-BOR-dex vs. BOR-dex |
17.9 vs. 24 | 80.5 vs. 50.0 | 9.3 vs. 4.4 months (HR 0.36, p = 0.0002) | 28.9 vs. 32.6 months (HR 0.96, NS) |
| CANDOR DARA-Kd vs. Kd |
32 vs. 36 | 90 vs. 67 * and 78 vs. 71 ** |
28.1 vs. 11.1 months (HR 0.46, p < 0.001) | Data not yet mature |
| IKEMA ISA-Kd vs. Kd |
32 vs. 34 | NT | NR vs. 15.7 months (HR 0.60, p = 0.56) | Data not yet mature |
| APOLLO DARA-POM-dex vs. POM-dex |
79 vs. 80 | 69 vs. 46 ¶ | 9.9 vs. 6.6 months (HR 0.66, p = Sig, NT) | Data not yet mature |
| ICARIA ISA-POM-dex vs. POM-dex |
93.5 vs. 91.5 | 59.0 vs. 31.4 | 11.4 vs. 5.59 months (HR 0.593, p = NT) | Data not yet mature |
| ELOQUENT-3 (Phase 2) ELO-POM-dex vs. POM-dex |
90 vs. 84 | 53 vs. 26 ¶ | 10.2 vs. 4.7 months (HR 0.56, p = NT) ¥ | 28.3 vs. 16.0 months (HR 0.42, p = NT) ¥ |
| BOSTON SEL-BOR-dex vs. BOR-dex |
37 vs. 39 ¶¶ | 67.5 vs. 53.2 | HR 0.63, p = NT PFS duration not reported for LEN ref. subgroup |
OS duration not reported for LEN ref. subgroup |
| BELLINI VEN-BOR-dex vs. BOR-dex |
20 vs. 28 | NT | NR vs. 14.8 months (HR 0.75, p = NT | HR 1.82, p = NT OS duration not reported for LEN ref. subgroup |
Abbreviations: POM—Pomalidomide, loDex—Low dose Dexamethasone, HiDex—High dose Dexamethasone, BOR—Bortezomib, DARA—Daratumumab, ISA—Isatuximib, ELO—Elotuzumab, SEL—Selinexor, VEN—Venetoclax, K—Carfilzomib, NS—Not significant, Sig—Significant, NR—Not Reached, NT—Not Tabulated. * one prior line of therapy, ** two to three prior lines of therapy, ¶—Intention to Treat population. ¥ Subgroup included dual LEN and PI refractory patients. Individual LEN refractory or PI refractory subgroups not reported. ¶¶—Not specified as refractory, only previous LEN exposure.