Sanofi has expanded the use of Sarclisa (isatuximab) in multiple myeloma in Europe by securing the label expansion from the European Medicines Agency (EMA).
The European regulatory agency approved Sarclisa as a combination treatment with Bristol Myers Squibb’s (BMS) Revlimid (lenalidomide) along with chemotherapies, Johnson & Johnson’s (J&J) Velcade (bortezomib) and dexamethasone, as a first-line treatment for adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).
Sarclisa is already approved in both Europe and the US for treating relapsed refractory multiple myeloma (MM) in combination with either Amgen’s Kyprolis (carfilzomib) or pomalidomide in addition to dexamethasone. According to the French company’s financials, Sarclisa is a high-grossing drug for Sanofi, raking in €341 million ($35.5 million) in the first nine months of 2024.
Phase III IMROZ trail data
The EMA approval follows a positive recommendation of the agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP’s support was based on the positive data from the open-label Phase III IMROZ study (NCT03319667).
The trial enrolled 446 participants with NDMM. It compared the safety and efficacy of adding Sarclisa to the standard-of-care (SoC) Velcade, Revlimid (lenalidomide), and dexamethasone. At a median follow-up of 59.7 months, participants in the Sarclisa and SoC combination group reported a 40% reduction in the risk of disease progression or death (the trial’s primary endpoint), compared to the SoC only group.
The median progression-free survival (PFS) was not reached in the treatment group, at a median follow-up of 59.7 months. The estimated PFS at 60 months was 63.2% for patients in the Sarclisa-SoC group, compared to 45.2% for SoC only arm.
Complete remission (CR) was seen in 74.7% of the participants in the Sarclisa-SoC arm, compared to 64.1% of patients taking SoC only. CR and minimal residual disease (MRD) negativity was achieved by 55% of the participants taking Sarclisa and SoC combination, compared to 40.9% of patients taking SoC only.
MRD was sustained for at least 12 months among nearly half (46.8%) of patients in the Sarclisa-SoC arm compared to less than one-quarter (24.3%) of patients taking SoC only. The median treatment duration for the Sarclisa-SoC combination was 53.2 months compared to 31.3 months for SoC only.
Grade three or worse treatment-emergent adverse events (TEAE) occurred in 91.6% and 84% of patients in the Sarclisa-SoC and SoC arms, respectively. TAE) of any grade led to treatment discontinuation in 22.8% of patients taking Sarclisa and SoC combination and 26% of patients taking SoC only.
