Sanofi's Sarclisa Combination Therapy Demonstrates Significant Efficacy in Relapsed Multiple Myeloma in Phase 3 IKEMA Trial

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Recently, Sanofi announced the latest results of the Phase 3 IKEMA clinical trial. The trial is being conducted in patients with relapsed multiple myeloma (MM) who have previously received 1-3 antimyeloma therapies and is evaluating the efficacy and safety of adding the CD38-targeting antibody Sarclisa (isatuximab) to a treatment regimen combining the proteasome inhibitor Kyprolis (carfilzomib) and dexamethasone (Kd).

As assessed by an independent review committee, the median progression-free survival (mPFS) in the Kd treatment group was 19.2 months (95% CI: 15.8-25.1; n=123), while the mPFS in the Sarclisa+Kd treatment group was 35.7 months (HR=0.58; 95% CI: 25.8-44.0; n=179). This result represents the longest mPFS observed in a clinical study investigating a proteasome inhibitor backbone therapy for second-line treatment of relapsed MM.

A PFS analysis conducted according to the U.S. FDA's censoring rules (applicable to approved U.S. prescribing information) showed an mPFS of 20.8 months in the Kd treatment group and an mPFS of 41.7 months in the Sarclisa+Kd treatment group (HR=0.59; 95% CI: 27.1–Not Calculable [NC]).

In the Kd treatment group, the median Time to Next Treatment (TTNT) was 25 months (95% CI: 17.9-31.3), while in the Sarclisa + Kd treatment group, it was 44.9 months (HR = 0.55; 95% CI: 31.6-NC). TTNT measures the time interval between the randomization date and the start date of the next treatment, thus reflecting the period of treatment benefit.

The safety and tolerability of Sarclisa observed in this analysis were consistent with the safety profile of Sarclisa in other clinical trials, and no new safety signals were observed.

Sarclisa is a monoclonal antibody drug that targets a specific epitope on the CD38 receptor of multiple myeloma cells. Sarclisa was launched in 2020 and has already been approved in many countries, including the United States and EU member states.

In the MM field, Sarclisa was launched nearly five years later than the competing CD38 antibody drug Darzalex (Janssen's JNJ-5476, daratumumab) from Johnson & Johnson. Darzalex was launched in 2015 and achieved global sales of $6.023 billion in 2021. In comparison, Sarclisa’s sales in 2021 were only 176 million euros.

Reference Source: Sanofi’s Sarclisa Combination Shows Positive Results in Multiple Myeloma Patients