Sanofi Highlights Data From Blood Cancer Drug Sarclisa In New Diagnosed Multiple Myeloma Patients

Monday, Sanofi SA SNY shared data from the IMROZ phase 3 study of Sarclisa, which enrolled 446 patients with newly diagnosed, transplant-ineligible multiple myeloma.

The company says that IMROZ is the first global phase 3 study of an anti-CD38 monoclonal antibody in combination with standard-of-care VRd to significantly improve PFS and show deep responses in this patient population who often have poor prognoses.

The results were shared in an oral presentation at the American Society of Clinical Oncology annual meeting.

The use of Sarclisa in combination with VRd in transplant-ineligible NDMM is investigational.

At the data cut-off of September 26, 2023, through the median follow-up of 59.7 months, the following were observed for Sarclisa-VRd compared to VRd.

The data demonstrated that Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen) reduced the risk of disease progression or death by 40%, compared to VRd followed by Rd.

At the median follow-up of 59.7 months, the median PFS with the Sarclisa-VRd combination was not reached versus 54.3 months with VRd.

The estimated progression-free survival at 60 months was 63.2% for patients treated with Sarclisa-VRd versus 45.2% for VRd.

Approximately three-quarters (74.7%) of patients treated with Sarclisa-VRd achieved a complete response (CR) compared to 64.1% of patients taking VRd.

More than half (55.5%) of patients treated with Sarclisa-VRd achieved MRD-negative CR, compared to 40.9% of patients taking VRd.

MRD was sustained for at least 12 months among nearly half (46.8%) of patients in the Sarclisa-VRd arm compared to less than one-quarter (24.3%) of patients taking VRd.

At the date of data cut-off, 47.2% of patients (125/263) treated with Sarclisa-VRd and 24.3% of patients (44/181) treated with VRd were still on treatment.

The median treatment duration for the Sarclisa-VRd combination was 53.2 months vs. 31.3 months for VRd.

The FDA accepted for Priority Review the supplemental application for Sarclisa combined with VRd for transplant-ineligible NDMM. A regulatory submission is also under review in the European Union.

If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care VRd in newly diagnosed patients not eligible for transplant, which would be the third indication for Sarclisa in multiple myeloma.

Price Action: SNY shares are down 0.20% at $49.15 at last check Tuesday.

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