Table 3.
Adverse effects of melflufen, selinexor, and belantamab mafodotin based on selected phase 2/3 pivotal clinical trials
| Melflufen | Selinexor | Belantamab mafodotin | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HORIZON [1] | OCEAN [2] | STORM [3] | STOMP [4] | BOSTON [5] | DREAMM-1 [7] | DREAMM-2 [8, 9] | ||||
|
Md (n = 157) |
Md (n = 246) |
Pd (n = 249) |
Sd (n = 123) |
SVd (n = 42) |
SVd (n = 195) |
Vd (n = 207) |
Phase 2 (n = 35) |
2.5 mg/kg (n = 95) |
3.4 mg/kg (n = 99) |
|
|
Hematologic AE (Gr.3, Gr. 4) |
||||||||||
| Anemia | 42%, < 1% | 40%, 2% | 17%, 1% | 43%, 1% | 12%, 0% | 36%, 16% | 23%, 10% | 14%, 0% | 20%, 0% | 22%, 3% |
| Thrombocytopenia | 25%, 51% | 32%, 31% | 6%, 4% | 36%, 33% | 17%, 29% | 60%†, 39%† | 27%, 17% | 26%, 9% | 8%, 12% | 11%, 22% |
| Neutropeniaa | 32%, 47% | 36%, 30% | 32%, 18% | 18%, 3% | 32%, 2% | 15%, 9% | 6%, 3% | 9%, 3% | 5%, 4% | 12%, 3% |
|
Non-hematologic AE all grade, Gr. ≥ 3) |
||||||||||
| Infusion reactions | - | - | - | - | - | - | - | 23d%, 6% | 21%, 3% | 16%, 1% |
| Peripheral neuropathy | - | - | - | - | 10%, 0% | 32%, 5% | 47%, 9% | - | - | - |
| GI side effects | ||||||||||
| Nausea | 32%, < 1% | 13%, < 1% | 7%, < 1% | 72%, 10% | 62%, 5% | 50%, 8% | 10%, 0% | 23%, 0% | 24%, 0% | 32%, 1% |
| Vomiting | 13%, 0% | - | - | 38%, 3% | 31%, 2% | 21%, 4% | 4%, 0% | 6%, 0% | 7%, 2% | 20%, 0% |
| Diarrhea | 27%, 0% | 14%, 1% | 8%, < 1% | 46%, 7% | 43%, 7% | 32%, 6% | 25%, < 1% | 17%, 3% | 13%, 1% | 15%, 1% |
| Weight loss | - | - | - | 50%, 1% | 19%, 0% | 26%, 2% | 12%, 1% | - | - | - |
| Fatiguee | 29%, 3% | 14%, 0% | 17%, 1% | 73%, 25% | 60%, 15% | 42%, 13% | 18%, 1% | 20%, 0% | 16%, 2% | 28%, 5% |
| Asthenia | 27%, 3% | 15%, 2% | 11%, 2% | - | - | 25%, 8% | 13%, 4% | - | 4%, 0% | 8%, 2% |
| Infections | ||||||||||
| Pneumoniab | 13%, 10% | 15%, 11% | 20%, 15% | 17%, 11% | - | 18%, 12% | 17%, 10% | 15%, 6% | 9%, 6% | 21%, 16% |
| URTIc | 16%, 2% | 18%, 3% | 21%, 2% | 22%, 2% | - | 18%, 3% | 15%, < 1% | 17%, 0% | 7%, 0% | 17%, 1% |
| Ocular AE | - | - | - | - | - | - | - | |||
| Keratopathy | - | - | - | - | - | - | - | 9%, 3% | 72%, 46% | 71%, 21% |
| Blurred vision | - | - | - | 11%, 2% | - | - | - | 46%, 0% | 25%, 4% | 30%, 2% |
| Dry eye | - | - | - | - | - | - | - | 34%, 3% | 15%, 1% | 23%, 0% |
| Eye pain | - | - | - | - | - | - | - | 6%, 3% | - | - |
| Photophobia | - | - | - | - | - | - | - | 23%, 0% | - | - |
| Decreased visual acuity | - | - | - | - | - | - | - | 3%, 3% | 54%, 31% | - |
| Hyponatremia | - | - | - | 37%, 22% | 10%, 5% | - | - | 3%, 0% | 5%, 2% | 7%, 4% |
†Thrombocytopenia occurred despite 18% of patients in the SVd arm being treated with thrombopoietin receptor agonists (compared to 1% of patients in the Vd arm)
aIncludes neutropenia, decreased neutrophil count, and febrile neutropenia
bIncludes pneumonia, COVID-19 pneumonia, lower respiratory tract infection, respiratory tract infection, influenzal pneumonia, pneumonia legionella, and pneumonia respiratory syncytial viral
cIncludes upper respiratory tract infection and bronchitis
dPer protocol, pre-medication was not allowed for the first infusion
eIncludes fatigue and lethargy