Findings from Phase 3 Multiple Myeloma Trial Announced

According to a story from BioSpace, Takeda Pharmaceutical Company Ltd. recently announced the release of results from a phase 3 clinical trial. This trial was testing the company’s drug ixazomib (marketed as NINLARO™) as part of a three part combination treatment including dexamethasone and lenalidomide in patients with newly diagnosed multiple myeloma that were not eligible for stem cell transplant. This combination was compared with dexamethasone, lenalidomide, and a placebo.

About Multiple Myeloma

Multiple myeloma, which is occasionally referred to as plasma cell myeloma, is a blood cancer that affects plasma cells. These are white blood cells that produce antibodies. The overall cause of multiple myeloma is not well understood, however, some risk factors have been identified. These include obesity, family history, smoldering myeloma, and monoclonal gammopathy of undetermined significance. These last two conditions have the potential to develop into multiple myeloma. Symptoms of this cancer include bone pain, infections, anemia, kidney failure, overly thick blood, confusion, fatigue, headaches, and amyloidosis. Treatment includes chemo, stem cell transplant, and other medications for relapsed disease, which is common. Five year survival rate is 49 percent in the US. To learn more about multiple myeloma, click here.

NINLARO is already approved in more than 65 countries in combination with dexamethasone and lenalidomide, but only in patients that had already been treated with at least one previous therapy. 

Study Findings

The results from this trial did not meet the progression free survival (PFS) primary endpoint. However, the median PFS in the NINLARO arm was 35.3 months versus only 21.8 month in the placebo arm. In the high risk patient group, NINLARO produced a 23.8 months median PFS versus 18 months. Additionally, the NINLARO cohort saw a complete response (CR) rate of 26 percent versus 14 percent in the placebo cohort. NINLARO also saw a longer time to progression (TTP) of 45.8 months versus 26.8 months.

The trial included a total of 75 adult patients that had been recently diagnosed and weren’t eligible for stem cell transplant. The results suggest that this combination could be of some benefit to patients in high risk groups that can’t get treated with stem cell transplant. 

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