On Thursday, Sanofi SA (NASDAQ:SNY) reported new results from the GMMG-HD7 phase 3 study of Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients.
The data show that Sarclisa, combined with RVd during induction therapy, significantly prolonged progression-free survival (PFS), resulting in a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd induction regardless of the maintenance regimen.
In December 2021, Sanofi and GMMG shared the results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients.
In May 2024, the FDA accepted for Priority Review the supplemental Biologics License Application for Sarclisa plus VRd combo for transplant-ineligible newly diagnosed multiple myeloma patients.
The target action date for the FDA decision is September 27, 2024. A regulatory submission is also under review in the European Union.
GMMG-HD7 is one of six phase 3 studies to report results for Sarclisa in multiple myeloma (MM), which includes four positive readouts of a Sarclisa-based quadruplet in the frontline setting.
In June, Sanofi shared data from the IMROZ phase 3 study of Sarclisa, which enrolled 446 patients with newly diagnosed, transplant-ineligible multiple myeloma.
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.
Price Action: SNY stock is up 0.52% at $52.07 at last check Thursday.
- Mounjaro Maker Eli Lilly's Bumper Q2 Earnings Exceeds Estimates, Hikes Outlook Again On Strong Diabetes And Weight Loss Drugs Sales.
Image by HJBC via Shutterstock