In STORM Part 2, a total of 122 patients were treated with XPOVIO (80 mg) in combination withdexamethasone (20 mg) on Days 1 and 3 of every week. Eighty‐three patients had RRMM that was refractoryto bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. Baseline patient demographicsand disease characteristics of these 83 patients are summarized in Table 4 and Table 5, respectively.
Treatment continued until disease progression, death, or unacceptable toxicity.
The major efficacy outcome measure was overall response rate (ORR), as assessed by an Independent ReviewCommittee (IRC) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria forMultiple Myeloma. The approval of XPOVIO was based upon the efficacy and safety in a prespecified subgroup
analysis of the 83 patients whose disease was refractory to bortezomib, carfilzomib, lenalidomide,pomalidomide, and daratumumab, as the benefit‐risk ratio appeared to be greater in this more heavilypretreated population than in the overall trial population. Overall response rate results are presented in
Table 6. The median time to first response was 4 weeks (range: 1 to 10 weeks). The median duration ofresponse was 3.8 months (95% CI: 2.3, not estimable)
Table 4: Baseline Demographics (STORM)
Demographic
STORM
(N = 83)
Median age, years (range) 65 (40, 86)
Age category, n (%)
<65 years 40 (48)
65 – 74 years 31 (37)
≥75 years 12 (15)
Sex, n (%)
Male 51 (61)
Female 32 (39)
Race, n (%)
White 58 (70)
Black or African American 13 (16)
Asian 2 (2)
Native Hawaiian or other Pacific Islander 1 (1)
Other 6 (7)
Missing 3 (4)
Table 5: Disease Characteristics (STORM)
Parameter
STORM
(N = 83)
Median years from diagnosis to start of study treatment (range) 7 (1, 23)
Prior treatment regimens, median (range) 8 (4, 18)
Documented refractory status, n (%)
Lenalidomide
Pomalidomide
Bortezomib
Carfilzomib
Daratumumab
83 (100)
83 (100)
83 (100)
83 (100)
83 (100)
Documented refractory status to specific combinations, n (%)
Bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab
Daratumumab in any combination
Daratumumab as single agent (+/‐ dexamethasone)
83 (100)
57 (69)
26 (31)
Previous stem cell transplant, n (%) 67 (81)
Revised International Staging System at Baseline, n (%)
I
II
III
Unknown
10 (12)
56 (68)
17 (21)
0
High‐risk cytogeneticsa
, n (%) 47 (57)
a. Includes any of del(17p)/p53, t(14; 16), t(4; 14), 1q21.
Table 6: Overall Response (STORM) as Assessed by the IRC per IMWG Criteria
Response
STORM
(N = 83)
Overall Response Rate (ORR)a
, n (%) 21 (25.3)
95% CI 16.4, 36
Stringent Complete Response (sCR) 1 (1)
Complete Response (CR) 0
Very Good Partial Response (VGPR) 4 (5)
Partial Response (PR) 16 (19)
a. Includes sCR + CR + VGPR + PR.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
XPOVIO (selinexor) are blue, round, bi‐convex, and film‐coated 20 mg tablets with “K20” debossed on one side
and nothing on the other side. Tablets are packaged in a child‐resistant blister pack. Four blister packs are
supplied per carton. The following four dose presentations are available:
Weekly dose Strength per tablet Carton Blister Pack NDC
80 mg twice weekly 20 mg 4 blister packs
(32 tablets total in
Each blister has
eight 20 mg
Outer carton NDC
72237‐101‐04
the carton) tablets
Blister pack NDC
72237‐101‐1 |
