Multiple Myeloma is a rare form of cancer that develops in the body’s plasma cells. These cells are normally responsible for helping the body fight infection. The accumulation of cancer cells in the bone marrow also results in a reduction of healthy cells as they are crowded out. A hallmark characteristic of this form of cancer is high levels of M proteins, an abnormal antibody.
For most people diagnosed with Multiple Myeloma the prognosis is still dim. While there are some treatment options available, it is clear research is still desperately needed. We need to find a more effective option for patients.
Sanofi has just announced positive results of their Phase 3 trial examining isatuximab as a potential therapeutic option for Multiple Myeloma. This trial is named ICARIA-MM and it is one of 4 ongoing trials of isatuxinab. Each are examining the effects of the drug when used in combination with the current standard therapies for the disease. All of these trials are Phase 3.
Isatuximab specifically targets CD83 which is highly expressed in Multiple Myeloma. Researchers believe it could promote both immunomodulatory activity and the death of tumor cells. Isatuxinab has already received Orphan Drug Designation by both the FDA and the European Medicines Agency.
The ICARIA-MM trial was specifically investigating the effect of isatuximab when used in combination with low dose dexamethasone and pomalidomide versus the effect of the standard of care treatments on their own. It included 307 patients who were diagnosed with relapsed/refractory Multiple Myeloma. The study was randomized and utilized 96 centers across 24 different countries. All of the participants had already tried at least two treatments including a proteasome inhibitor (alone or in combination) and at least two consecutive cycles of lenalidomide.
Patients received 10mg/kg of isatuximab each week for four weeks. After this period they received the treatment once every other week for 28-day cycles in addition to standard of care treatment.
Isatuximab met the primary endpoint which was prolonging progression free survival. It also met the secondary endpoint which evaluated the drugs safety.
The results of this trial should form the basis of Sanofi’s regulatory submissions for isatuximab. The company plans to submit their application later this year. Sanofi is excited about these trial results and is looking forward to working with the FDA to hopefully bring this new therapy to Multiple Myeloma patients soon.
You can read more about this Phase 3 trial and isatuximab here.