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During the 17th International Myeloma Workshop (IMW), Ajai Chari from Icahn School of Medicine at Mount Sinai, New York, NY, US, presented the latest results of the phase II PLEIADES trial (NCT03412565).1
Daratumumab (dara) is known to be efficacious in patients with multiple myeloma (MM) when administered intravenously and is licensed as a monotherapy or for use in combination with other treatments for MM both in Europe and the US.2 A highly permeable subcutaneous formulation of dara (dara SC) is currently being assessed as an alternative to intravenous dara. In the phase III COMLUMBA trial,3 dara SC monotherapy showed similar activity and safety to intravenous DARA but with fewer infusion-related reactions (IRRs). The phase II PLEIADES trial sought to investigate the efficacy and safety of dara SC when combined with standard MM regimens like bortezomib (V), lenalidomide (R) and dexamethasone (d, VRd), Rd or V, melphalan, and prednisone (VMP), in both newly-diagnosed MM (NDMM) and relapsed/refractory MM (RRMM).
This trial enrolled and separately assessed three distinct patient populations:
This trial enrolled and separately assessed three distinct patient populations who received therapies as below:
Table 1. Baseline characteristics1
ECOG; Eastern Cooperative Oncology Group, ISS; international staging system |
|||
|
Transplant-eligible NDMM dara SC + VRd (n= 67) |
Transplant-ineligible NDMM dara SC + VMP (n= 67) |
RRMM dara SC + Rd (n= 65) |
---|---|---|---|
Median age (range), years |
59 (33-76) |
75 (66-86) |
69 (33-82) |
Male patients |
71.6% |
46.3% |
69.2% |
ECOG score: 0 1 2 |
59.7% 38.8% 1.5% |
37.3% 56.7% 6.0% |
55.4% 44.6% 0 |
Median number of prior lines of therapy (range) |
Not applicable (N/A) |
N/A |
1 (1-5) |
Cytogenetic risk: Standard High |
75.5% 24.5% |
80.5% 19.5% |
64.5% 35.5% |
ISS stage: I II III |
44.8% 34.3% 20.9% |
32.8% 44.8% 22.4% |
42.2% 29.7% 28.1% |
All primary endpoints were met for all cohorts (Table 2)
Table 2. Response outcomes with dara SC combination treatments1
Dara, daratumumab; NDMM, newly diagnosed multiple myeloma; RR, relapsed/refractory; SC, subcutaneous; VMP, bortezomib, melphalan and prednisolone; VRd, bortezomib, lenalidomide and dexamethasone |
|||
|
Transplant-eligible NDMM dara SC + VRd (n= 67)
Post-induction cycle four |
Transplant-ineligible NDMM dara SC + VMP (n= 67)
At 11 months |
RRMM dara SC + Rd (n= 65)
At 11.2 months |
---|---|---|---|
ORR |
97.0% |
89.6% |
93.8% |
Complete response (CR) |
7.5% |
16.4% |
21.5% |
Stringent CR (sCR) |
9.0% |
16.4% |
10.8% |
VGPR |
71.6% |
43.3% |
43.1% |
Partial response (PR) |
25.4% |
13.4% |
18.5% |
Table 3. Safety summary1
Dara, daratumumab; NDMM, newly diagnosed multiple myeloma; RR, relapsed/refractory; SC, subcutaneous; VMP, bortezomib, melphalan and prednisolone; VRd, bortezomib, lenalidomide and dexamethasone; TEAE, treatment-related adverse event | |||
|
Transplant-eligible NDMM dara SC + VRd (n= 67)
|
Transplant-ineligible NDMM dara SC + VMP (n= 67) |
RRMM dara SC + Rd (n= 65) |
---|---|---|---|
Any TEAE |
100% |
100% |
100% |
Serious TEAE |
28.4% |
38.8% |
47.7% |
Grade 3-4 TEAE |
56.7% |
68.7% |
83.1% |
TEAEs leading to treatment discontinuation |
1.5% |
3.0% |
7.7% |
Fatal TEAE |
1.5% |
3.0% |
3.1% |
The investigators concluded that dara SC in combination with VRd, VMP, or Rd leads to similar efficacy and safety outcomes in patients with NDMM or RRMM, as intravenous dara in the same patient populations and treatment combinations, respectively. However, dara SC was associated with lower rates of IRRs than its intravenous formulation, making it a more favorable option for patients with MM.
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