Vor Bio announces Phase 3 study on telitacicept in SLE met primary endpoint

Vor Bio (VOR) announced that results from a Phase 3 study in China evaluating telitacicept in systemic lupus erythematosus, SLE, sponsored by its collaborator, RemeGen, were published in The New England Journal of Medicine, NEJM. The study, conducted at 42 hospitals in China, evaluated telitacicept in 335 patients with active SLE despite standard therapy. The study met its primary endpoint with 67.1% of patients who received telitacicept achieving a modified SLE Responder Index-4 response compared with 32.7% on placebo at week 52. More telitacicept-treated patients met a modified SRI-4 response as early as week 4 than those who received placebo. This difference was sustained at week 52. At week 52 SELENA-SLEDAI score reduction from baseline of greater than or equal to4 points occurred in 70.1% of the telitacicept group versus 40.5% of placebo patients. Greater reductions were observed with telitacicept. Median time to flare was 198 days on telitacicept versus 115 days on placebo. The proportion pf patients taking less than or equal to7.5mg/day of glucocorticoid or with greater than or equal to25% reduction in glucocorticoid dose from baseline over weeks 44-52 was 44.9% in the telitacicept group versus 34.7% for placebo. Among patients with baseline proteinuria, more achieved clinically meaningful reductions .