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May 16, 2022

Sanofi reports positive Phase III multiple myeloma trial results

A monoclonal antibody, Sarclisa acts on an epitope on the CD38 receptor on multiple myeloma (MM) cells.

Sanofi has reported data from the Phase III IKEMA clinical trial where its Sarclisa (isatuximab) plus carfilzomib and dexamethasone (Kd) combination therapy showed exceptional median progression free survival (mPFS) in relapsed multiple myeloma patients.

The treatment is indicated for patients who are receiving proteasome inhibitor therapy.

A monoclonal antibody, Sarclisa acts on an epitope on the CD38 receptor on multiple myeloma (MM) cells. 

It can act through various mechanisms of action including programmed tumour cell death and immunomodulatory activity. 

The multicentre, randomised, open-label trial enrolled 302 relapsed MM patients across 69 centres in 16 countries. 

In the trial, all subjects had received one to three anti-myeloma therapies earlier. 

Progression free survival (PFS) was the trial’s primary endpoint. 

Overall response rate, rate of complete response or better, rate of very good partial response or better, rate of minimal residual disease-negativity, overall survival and safety were included as the trial’s secondary endpoints.

Findings showed that treatment with Sarclisa combination therapy offered an mPFS of 35.7 months versus 19.2 months in subjects who received Kd alone. 

The latest results indicate the longest mPFS among trials analysing a proteasome inhibitor backbone in the second-line setting to treat relapsed MM.

According to a PFS assessment after the US Food and Drug Administration recommendations on censoring rules, the combination therapy offered an mPFS of 41.7 months as against 20.8 months in subjects who received Kd alone.

Time to next treatment was 44.9 months for patients treated with Sarclisa combination therapy versus 25 months for those treated with Kd alone.

The safety and tolerability of Sarclisa seen in this assessment were in line with the safety profile of the therapy in other trials without any new safety signals reported. 

Sanofi Oncology Clinical Development and Pediatric Innovation global head Peter Adamson said: “To observe progression free survival of more than three years in patients with relapsed multiple myeloma when Sarclisa was added to a proteasome inhibitor backbone of therapy is unprecedented and reinforces our confidence in Sarclisa as a potential best in class anti-CD38 antibody.”

In March this year, the company reported that its Phase II AMEERA-3 trial of amcenestrant in breast cancer patients failed to meet the primary endpoint of boosting PFS.

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