Analysis of Phase 3 Study Shows Inolimomab has Long-term Clinical Benefit for Graft-Versus-Host-Disease

About Graft-Versus-Host-Disease (GvHD)

Graft-Versus-Host-Disease (GvHD) occurs when a patient’s body rejects cells which have been transplanted. For instance, it may develop following a stem cell transplant or a bone marrow transplant. The acute form of the disease occurs within six months of the transplant and is normally treatable with steroids. The chronic form of the condition can unfortunately last a lifetime and usually develops three months or more after transplant.

Transplants are usually only used as a last resort for conditions such as severe immunodeficiency or blood cancer. Unfortunately, half of patients who receive transplants face some form of complication. GVHD specifically affects somewhere between 30% and 55% of patients and unfortunately, 30-55% of patients with the acute form of the disease become resistant to the steroids used to treat it. In Europe alone, 4,000 people die each year from the condition.

A study conducted eight and a half years ago indicated that inolimomab is an effective treatment for the acute form of the disease which is also steroid resistant (SR-aGvHD). But researchers wanted to assess the long-term effects of this treatment and just completed a follow-up of the Phase III study of the drug.

Thankfully, inolimomab still showed a clear clinical benefit 8.5 years after treatment and superiority compared to anti-thymocyte globulin (ATG).

The Study

This study was conducted by ELSALYS Biotech. It included 100 participants who had been treated with inolimomab or anti-thymocyte globulin between the years of 2009 and 2015. It occurred across 15 trial centers and patients were monitored for one year.

30.6% of the patients who received inolimomab reached the Overall Survival endpoint versus 19.6% of patients who received ATG. This difference equates to a 43% reduction in the risk of death for those taking inolimomab.

Overall, this follow-up trial shows that the positive effects of the drug are sustained long-term. The safety profile of the drug also remained favorable. Researchers believe these encouraging results may help to ease regulatory acceptance of the drug for Compassionate Use in France, Europe, and the United States.

The findings of this study were published in a Letter to Blood.

You can read more about this study and inolimomab as a treatment for SR-aGvHD here.


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