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The proteasome inhibitor, bortezomib, has demonstrated clinical efficacy in combination regimens for MM. However, prolonged treatment with bortezomib is associated with high rates of peripheral neuropathy (PN). The phase III BOSTON trial (NCT03110562) aimed to compare the efficacy of selinexor + bortezomib + dexamethasone (SVd) with bortezomib + dexamethasone (Vd) and to determine if SVd reduces the rate of PN compared with Vd alone in patients with relapsed/refractory multiple myeloma (RRMM).
At this year’s virtual ASCO Annual Meeting, Meletios A. Dimopoulos outlined the initial results, summarized below.1
Table 1. Dosing schedules of SVD vs Vd1
SVd, selinexor + bortezomib + dexamethasone; Vd, bortezomib + dexamethasone *35-day cycles †Vd biweekly 21-day cycles (Cycles 1–8); Vd weekly 35-day cycles (Cycles ≥ 9) |
||
|
Regimen |
|
SVd* |
Vd† |
|
Selinexor, 100 mg orally
|
Days 1, 8, 15, 22, 29 |
— |
Dexamethasone, 20 mg orally |
Days 1, 2, 8, 9, 15, 16, 22, 23, 29, 30 |
Cycles 1–8: Days 1, 2, 4, 5, 8, 9, 11, 12 Cycles ≥ 9: Days 1, 2, 8, 9, 15, 16, 22, 23, 29, 30 |
Bortezomib, 1.3 mg/m2 SC
|
Days 1, 8, 15, 22 |
Cycles 1–8: Days 1, 4, 8, 11 Cycles ≥ 9: Days 1, 8, 15, 22 |
Table 2. Baseline characteristics of patients enrolled in the BOSTON study1
Characteristic |
SVd (n = 195) |
Vd (n = 207) |
PR, partial response; SVd, selinexor + bortezomib + dexamethasone; Vd, bortezomib + dexamethasone * del (17p), t(14;16), t(14;14) or amp 1q21 † Patients previously exposed to proteasome inhibitors should have achieved at least a PR |
||
Median age, years (range) |
66 (40–87) |
67 (38–90) |
Male, % |
59 |
56 |
Median time from diagnosis, years (range) |
3.8 (0.4–23) |
3.6 (0.4–22) |
High-risk cytogenetics*, % |
50 |
46 |
Creatinine clearance 30–60 mL/min, % |
27 |
29 |
Number of prior lines of therapy, % 1 2 3 |
51 33 16 |
48 31 21 |
Prior treatment, % |
|
|
Bortezomib† |
68.7 |
70.0 |
Carfilzomib† |
10.3 |
10.1 |
Lenalidomide |
39.5 |
37.2 |
Daratumumab |
5.6 |
2.9 |
Table 3. Patient outcomes to SVd vs Vd1
HR, hazard ratio; PFS, progression-free survival; SVd, selinexor + bortezomib + dexamethasone; Vd, bortezomib + dexamethasone * Data cutoff: February 18, 2020. |
|||
Patient outcome* |
SVd (n = 195) |
Vd (n = 207) |
p value |
Median follow-up, months |
13.2 |
16.5 |
— |
PFS, months |
13.93 |
9.46 |
HR 0.70, 0.0066 |
ORR, % |
76.4 |
62.3 |
0.0012 |
Aged ≥ 65 years |
76.1 |
64.4 |
0.0243 |
High-risk cytogenetics |
77.3 |
55.8 |
0.0008 |
Creatinine clearance 30 – 60 mL/min |
79.2 |
56.7 |
0.0055 |
1 prior line of therapy |
80.8 |
65.7 |
0.0082 |
Prior bortezomib treatment |
77.6 |
59.3 |
0.0005 |
Prior lenalidomide treatment |
67.5 |
53.2 |
0.0354 |
Median duration of response, months |
20.3 |
12.9 |
— |
Figure 1. ORRs to SVd vs Vd in the overall population1
CR, complete response; ORR, overall response rate; PR, partial response; sCR, stringent complete response; SVd, selinexor + bortezomib + dexamethasone; Vd, bortezomib + dexamethasone; VGPR, very good partial response
Table 4. Common Grade 3–4 TRAEs observed in > 5% of patients receiving SVd vs Vd1
TRAE, treatment-related adverse event; SVd, selinexor + bortezomib + dexamethasone; Vd, bortezomib + dexamethasone |
||
Grade 3–4 TRAEs |
SVd (n = 195) |
Vd (n = 207) |
Thrombocytopenia |
39.5 |
17.2 |
Anemia |
15.9 |
9.8 |
Fatigue |
13.3 |
1.0 |
Neutropenia |
8.7 |
3.4 |
Cataract |
8.7 |
1.5 |
Asthenia |
8.2 |
4.4 |
Nausea |
7.7 |
0 |
Diarrhea |
6.2 |
0.5 |
QW SVd demonstrated significantly superior efficacy over BIW Vd, reducing the risk of progression or death by 30%, and standing as a novel, IMiD-free triplet therapy for patients with RRMM. QW administration of SVd has the potential to reduce hospital visits by up to 40% while also reducing levels of bortezomib-associated PN.1,2
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