Sanofi Announces Sarclisa-Based Combination Therapy Reduces Risk of Disease Progression or Death by 47% in Relapsed Multiple Myeloma

Today, Sanofi announced that its anti-CD38 antibody Sarclisa (isatuximab), in combination with the standard regimen of carfilzomib and dexamethasone (Kd), met the primary endpoint in a Phase 3 clinical trial for patients with relapsed multiple myeloma (MM). Compared to the standard treatment consisting of carfilzomib and dexamethasone alone, the Sarclisa combination reduced the risk of disease progression or death by 47% (HR=0.531, p=0.0007, n=179). The Sarclisa combination demonstrated consistent therapeutic benefits across multiple subgroups compared to Kd monotherapy.

Multiple myeloma (MM) is the second most common hematologic malignancy, with over 130,000 newly diagnosed cases globally each year. Despite available treatments, MM remains an incurable malignant disease and is associated with a significant patient burden. As there is no cure for MM, most patients experience relapse. Relapsed MM refers to the recurrence of cancer after treatment or following a period of remission.

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It works through multiple mechanisms of action, including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapies such as Sarclisa.

The IKEMA trial, a randomized, multicenter, open-label Phase 3 clinical study, enrolled 302 patients with relapsed multiple myeloma (MM) across 69 centers in 16 countries. At the time of the interim analysis, the median progression-free survival (PFS) was 19.15 months in the Kd treatment group, whereas the median PFS had not yet been reached in patients receiving Sarclisa combination therapy.

Meanwhile, the complete response (CR) rate was 39.7% in the Sarclisa combination therapy group versus 27.6% in the standard-of-care group. Minimal residual disease (MRD)-negative complete response was achieved by 29.6% of patients in the Sarclisa combination therapy group compared with 13% in the standard-of-care group, indicating that nearly 30% of patients receiving Sarclisa-based combination therapy had no detectable multiple myeloma (MM) by next-generation sequencing (NGS).

“This is the second Phase 3 trial demonstrating the superiority of Sarclisa-based combination therapy over standard regimens. Growing evidence suggests that our anti-CD38 monoclonal antibody has the potential to bring meaningful change for patients,” said Dr. John Reed, Global Head of Research and Development at Sanofi. “We believe Sarclisa has the potential to become the preferred anti-CD38 antibody for the treatment of multiple myeloma. We look forward to seeing the results of future clinical trials to understand the impact of Sarclisa in earlier stages of the disease.”

Original Title: Sanofi’s CD38 Antibody Combination Outperforms Standard Therapy, Reducing Risk of Disease Progression by 47% in MM Patients

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