Elotuzumab delays disease progression of relapsed multiple myeloma

This study examined the safety and effectiveness of elotuzumab (Empliciti) for relapsed multiple myeloma. Researchers concluded that elotuzumab combined with lenalidomide (Revlimid) and dexamethasone was safe and effective at improving treatment outcomes for relapsed multiple myeloma.

Standard treatment for multiple myeloma involves giving high doses of chemotherapy and replacing blood-forming cells destroyed by the cancer treatment with a stem cell transplant. This has significantly improved response and survival rates among patients. However, nearly all patients will relapse over time and will develop resistance to standard treatment. A treatment option for relapsed multiple myeloma is biologic therapy that uses the patient's immune system to fight cancer. Monoclonal antibodies, such as elotuzumab, are a type of biologic therapy composed of antibodies that attach to cancer cells. Early studies have reported promising results with elotuzumab for relapsed multiple myeloma.

The aim of this late-phase study was to examine the safety and effectiveness of elotuzumab for relapsed multiple myeloma.

646 patients with progressing multiple myeloma after 1 to 3 previous treatments were included. Patients were randomly assigned to one of two treatment groups. 321 patients were treated with elotuzumab plus the biologic therapy lenalidomide and the steroid drug dexamethasone. 325 patients were treated with lenalidomide and dexamethasone alone (control group). Patients were followed for an average of 24.5 months.

In the elotuzumab group, 165 progressions and 14 deaths were observed over the study period. In the control group, 183 progressions and 22 deaths were observed.

 Average time to disease progression in the elotuzumab group was 19.4 months. This was significantly longer compared to the control group (14.9 months). 41% of patients in the elotuzumab group were progression-free at 2 years. This was significantly greater compared to 27% in the control group.

These results were unaffected by age, disease stage, treatment resistance to the most recent line of therapy, and previous treatment types. The greatest benefit in progression-free survival was observed among patients who had multiple myeloma for 3.5 years or more. Among these patients, average overall survival (time from treatment until death from any cause) was 26 months in the elotuzumab group compared to 17.3 months in the control group.

Serious side effects were reported in 65% of patients in the elotuzumab group and in 57% of patients in the control group. These included low neutrophil and lymphocyte levels (types of white blood cells) and anemia (low red blood cell levels) as well as fatigue, fever, and diarrhea.

Researchers concluded that adding elotuzumab to treatment reduced the risk of disease progression by 30% in patients with relapsed multiple myeloma.