Sanofi says Sarclisa Phase 3 trial met primary endpoint

The Phase 3 IMROZ trial evaluating the investigational use of Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival, or PFS, compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma, Sanofi announced. “This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care,” the company said. The safety and tolerability of Sarclisa observed in this trial was consistent with the established safety profile of Sarclisa and VRd. Study results will be submitted for presentation at an upcoming medical meeting and form the basis of a future regulatory submission.