Table 2.
Efficacy outcomes of melflufen, selinexor, and belantamab mafodotin based on selected phase 2/3 pivotal clinical trials
| Med. prior lines | Prior PI (%), IMID (%), antiCD38 mAb (%) | mFU (months) | Responses (ORR%, ≥ CR%) | mPFS (months) | Median time to first response (months) | |
|---|---|---|---|---|---|---|
| Melflufen | ||||||
| HORIZON [1] | Prior ref.: | |||||
| Md (n = 157) | 5 (r. 2–12) |
64, 97, 80 13% ref. to melphalan |
14 | 29%, 1% | 4.2 (95% CI 3.4–4.9) |
Median time to ≥ PR: 1.9 (r. 1–7.4) |
| OCEAN [2] | Prior exposure: | |||||
|
I: Md (n = 249) C: Pd (n = 249) |
I: 3 (IQR 2–3) C: 3 (IQR 2–3) |
I: 66, 100, 20 C: 65, 100, 16 |
I: 19.8 C: 18.6 |
I: 33%, 3% C: 27%, 1% |
I: 6.8 (95% CI 5.0–8.5) C: 4.9 (95% CI 4.2–5.7) |
I: 2.1 (IQR 1.1–3.7) C: 2.0 (IQR 1.1–2.9) |
| Selinexor | ||||||
|
STORM [3] Sd (n = 122) |
7 (range 3–18) |
Prior ref.: 100, 100, 100 |
- | 26%, 2% | 3.7 (95% CU 3–5.3) | - |
|
STOMP [4] SVd (n = 42) |
3 (range 1–11) |
PI ref.: 50% PI + IMID ref.: 45% |
- | 63%, 8% | 9 (n = 40 evaluable patients) | 1.2 (IQR 1.2–1.7) |
| BOSTON [5] | 1 prior line (%): | Prior exposure: | If ≥ PR: | |||
|
SVd (n = 195) Vd (n = 207) |
I: 51% C: 48% |
I: 82, 45, 6 C: 87, 43, 3 |
I: 13.2 C: 16.5 |
I: 76%, 17% C: 62%, 10% |
I: 13.9 (11.7–NE) C: 9.5 (8.1–10.8)a |
I: 1.1 (IQR 0.8–1.6) C: 1.4 (IQR 0.8–1.6) |
| Belantamab mafodotin | ||||||
| DREAMM-1 [7] | ≥ 5 prior lines (%) | Prior ref.: | ||||
| P1(n = 38): 0.03–4.6 | P1: 76% | P1: 0, 0, 0 | ||||
|
mg/kg P2 (n = 35): 3.4 mg/kg |
P2: 57% | P2: 97, 91, 37 | P2: 12.5 (r. 0.7–23.2) | P2: 60%, 14% | P2: 12 (95% CI 3.1–NE) | P2: 1.2 (95% CI 0.7–1.4) |
| DREAMM-2 [9] | Prior ref.: | |||||
|
Arm 1 (n = 97): 2.5 mg/kg Arm 2 (n = 99): 3.4 mg/kg |
Arm 1: 7 (range 3–21) Arm 2: 6 (range 3–21) |
Arm 1: 76, 90, 100 Arm 2: 75, 89, 92 |
Arm 1: 12.4 (r. 0.1–17.9) Arm 2: 6.9 (IQR 4.8–7.9) |
Arm 1: 32%, 7% Arm 2: 34%, 3% |
Arm 1: 2.8 (95% CI 1.6–3.6) Arm 2: 4.9 (95% CI 2.3–6.2) |
- - |
Bold data: Investigational agents
Abbreviations: belamaf, belantamab mafodotin; Ref, refractory; int, intolerant; P1, phase 1 trial; P2, phase 2 trial; ORR, overall response rate; I, intervention; C, comparator; r., range; IQR, interquartile range
aOf the 30% of patients progressing on Vd that crossed over and received SVd, only 19% responded with the addition of selinexor