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The phase III OPTIMISMM trial (NCT01734928) evaluated the efficacy and safety of pomalidomide (P), bortezomib (V) and dexamethasone (d, PVd) compared to Vd alone in patients with relapsed/refractory multiple myeloma (RRMM). Patients enrolled in OPTIMISMM were all previously exposed to lenalidomide (len) and 70% were len-refractory.1
The full trial results showed PVd significantly improved progression-free survival (PFS) compared to Vd alone (PVd vs Vd: 11.2 vs 7.1 months, p< 0.0001) with an overall response rate (ORR) of 82.2% in the PVd arm compared to 50% in the Vd arm (p< 0.0001). Additionally, the authors demonstrated an improvement in PFS in patients who had received only one prior line of therapy; including those who were len-refractory (Table 1).1
Table 1. PFS in patients who received one prior line of therapy1
|
Total cohort |
Len-refractory |
Len non-refractory |
|||
---|---|---|---|---|---|---|
|
PVd n= 111 |
Vd n= 115 |
PVd n= 64 |
Vd n= 65 |
PVd n= 47 |
Vd n= 50 |
Median PFS, months |
20.73 |
11.63 |
17.84 |
9.49 |
22.01 |
11.96 |
HR, 95% CI, p value |
0.54 0.36–0.82 p= 0.0027 |
NR |
NR |
|
||
d, dexamethasone; HR, hazard ratio; len, lenalidomde; NR, not reported; P, pomalidomide; PFS, progression free survival; V, bortezomib |
Full results from the OPTIMISMM trial were recently published in Lancet Oncology and are available on the Multiple Myeloma (MM) Hub here.
During the XVII International Myeloma Workshop (IMW), Boston, US, Meletios Dimopoulos, National and Kapodistrian University of Athens, Athens, GR, presented a subgroup analysis of the OPTIMISMM trial comparing PVd to Vd as second-line treatment following frontline len treatment in patients who were, or were not, exposed to V.2
Of the intention-to-treat (ITT) population (n= 559), 226 had received only one prior line of treatment. Of these, 134 (59%) received V as part of induction treatment (subsequently randomized to PVd [n= 67] or Vd [n= 67]), compared to 92 (41%) who did not (subsequently randomized to PVd [n= 44] or Vd [n= 48]).
Table 2. PFS and best response by prior exposure to V
|
With prior V |
Without prior V |
||
---|---|---|---|---|
|
PVd (n= 67) |
Vd (n= 67) |
PVd (n= 44) |
Vd (n= 48) |
Median PFS (months), 95% CI |
17.8 15.1–20.8 |
12 7.9–21.1 |
20.7 8.3–not evaluable |
9.5 6.3–16.2 |
HR, 95% CI, p value |
0.47 0.26–0.82 p= 0.0068 |
0.62 0.35–1.11 p= 0.1055 |
||
Response rates by prior V exposure (%) |
||||
ORR |
89.6 |
49.3 |
90.9 |
62.5 |
Complete response (CR)/ stringent CR (sCR) |
19.4 |
3 |
15.9 |
10.4 |
Very good partial response (VGPR) |
43.3 |
13.4 |
43.2 |
20.8 |
Partial response (PR) |
26.9 |
32.8 |
31.8 |
31.3 |
Stable disease (SD) |
9 |
37.3 |
9.1 |
31.3 |
PD |
1.5 |
4.5 |
0 |
2.1 |
Not evaluable |
0 |
9 |
0 |
4.2 |
Duration of response (DoR), months |
20.7 |
13.8 |
20 |
14.8 |
d, dexamethasone; P, pomalidomide; PFS, progression free survival; V, bortezomib |
The most common treatment-emergent adverse events (AEs) were neutropenia, infections and thrombocytopenia (Table 3). The safety profile of PVd was equivalent to those of each of the individual drugs.
Table 3. Safety by prior V exposure
|
With prior V |
Without prior V |
||
---|---|---|---|---|
|
PVd (n= 67) |
Vd (n= 64) |
PVd (n= 44) |
Vd (n= 46) |
Median cycles of treatment |
15 |
9 |
13.5 |
9 |
Grade III/IV hematologic AEs, % |
||||
Neutropenia |
45 |
11 |
23 |
9 |
Thrombocytopenia |
24 |
27 |
14 |
13 |
Anemia |
10 |
8 |
11 |
4 |
Grade III/IV non-hematologic AEs, % |
||||
Infections |
27 |
16 |
32 |
15 |
Pneumonia |
7 |
5 |
11 |
7 |
Peripheral sensory neuropathy |
10 |
0 |
7 |
9 |
Fatigue |
10 |
3 |
5 |
2 |
Hyperglycemia |
9 |
3 |
7 |
15 |
Diarrhea |
4 |
5 |
11 |
7 |
Syncope |
4 |
2 |
2 |
9 |
AEs, adverse events; d, dexamethasone P, pomalidomide; V, bortezomib |
The results of this subgroup analysis indicate that second-line treatment with PVd was effective in len-pre-treated patients with RRMM, regardless of prior exposure to V.
This analysis supports the use of P-based regimens after one prior line of treatment in patients with RRMM immediately after exposure to len and V.
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