Table 4.
Investigational agents: Immunological approaches | ||||
---|---|---|---|---|
Trial | Phase | Agents | Outcome | References |
KarMMa | II |
idecabtagene vicleucel ide-cel, bb2121 |
ORR 73%, CR 33%, 26% MRD-, median PFS 8.8 months | [53] |
CARTITUDE-1 | I/II | Ciltacabtagene autoleucel (cilta-cel) | ORR 96.9%, 34% MRD-negative CR, 2-year PFS 60.5% | [54] |
MajesTEC-1 | I/II | teclistimab | ORR 62%, 9-month PFS 58.5% | [55, 56] |
Investigational agents: BCL-2 inhibition | ||||
II | Venetoclax-Kd | ORR 80% in all patients, 92% in t(11:14). ≥CRR 41% median PFS 22.8 months | [59] | |
BELLINI | III | Venetoclax-Vd vs. Vd |
Median PFS 22.4 vs. 11.5 months, increased overall mortality with Venetoclax. Venetoclax-Vd increased PFS in patients with t(11;14) (HR = 0.10) or high bcl-2 expression (HR = 0.26), also increased MRD- rate (19% vs. 0) with no increased mortality |
[60] |
Kd carfilzomib-dexamethasone, Vd bortezomib-dexamethasone.