Extended Indications of BMS Innovative Immunotherapy for multiple myeloma

BMS announced that FDA approved the company's innovative immunotherapy Empliciti (elotuzumab) and pomalidomide and dexamethasone to treat patients with specific relapsed/refractory multiple myeloma (MM). These patients have to receive at least two prophase treatments, including lenalidomide and a protease inhibitor. 

MM is a malignant blood cancer caused by the canceration of plasma cells in bone marrow. It is the third most common blood cancer in the United States. The proliferation of cancerous plasma cells in bone marrow not only affects the production of normal red blood cells and white blood cells, but also causes excessive accumulation of abnormal antibodies in the body. Patients usually have symptoms of bone pain, nausea, loss of appetite, susceptibility to infection and anemia. It is estimated that more than 30,000 people will be diagnosed with MM in the United States in 2018, and about 13,000 will die as a result. Although there are many methods to control MM, such as chemotherapy, glucocorticoids and targeted drugs, many patients still have resistance to all approved therapies. Therefore, these patients urgently need new effective therapies to help them control MM. 

Empliciti is an innovative immune stimulating antibody developed by BMS and AbbVie, which can specifically target SLAMF7 glycoprotein on cell surface. This glycoprotein is expressed on the surface of myeloma cells and also on the surface of natural killer cells (NK). Empliciti has two mechanisms. On the one hand, it can directly activate NK cells through SLAMF7 signaling pathway, thereby enhancing the immune response. On the other hand, it can bind to SLAMF7 protein on the surface of myeloma cells and label these tumor cells so that NK cells can kill tumor cells through antibody-based cytotoxicity.

In a randomized open-label phase 2 clinical trial called ELOQUENT-3, Empliciti double increased the progression-free survival (PFS) and overall remission rate (ORR) of relapsed/refractory MM patients compared with the combination therapy of pomalidomide and dexamethasone (EPd). The median PFS of EPd was 10.25 months and Pd was 4.67 months. EPd reduced the risk of disease progression by 46% (HR: 0.54, 95% CI: 0.34-0.86, P = 0.0078). The ORR of EPd group was 53.3%, which was 26.3% significantly higher than that of Pd group (95% CI: 15.5-39.7, P = 0.0029).

"Recurrence of cancer is a serious challenge for MM patients, especially because they have tried many therapies," said Paul Guisti, president and CEO of the MM Research Foundation. "Empliciti and pomalidomide combined with dexamethasone provide immunotherapy for relapsed/refractory MM patients as an exciting new treatment option. 

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