Clinically meaningful ORR to zetomipzomib seen in patients with lupus nephritis
Positive topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib in patients with active lupus nephritis (LN) were announced by Kezar Life Sciences, Inc, in a press release.
In this phase 2 clinical trial open-label study, patients with LN were treated with 60 mg of zetomipzomib subcutaneously once weekly in addition to stable background therapy for 24 weeks; 17 of 21 patients enrolled in the trial reached end of treatment. There was no induction therapy period.
The primary efficacy endpoint of the proportion of patients achieving an overall renal response (ORR), measured as a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at the end of treatment compared to baseline was achieved by 64.7% of patients. A complete renal response of 0.5 UPCR or less was achieved in 35.2% of patients.
The benefits of treatment were maintained following the end of treatment; at Week 29 94.1% reached an ORR and 6 out of 17 patients maintained a CRR.
“The MISSION Phase 2 topline results show a clinically meaningful overall renal response to zetomipzomib after 6 months, without high-dose induction therapy. Patients in the trial also experienced reductions in extra-renal manifestations of lupus. Zetomipzomib appears to be immunomodulatory, well-tolerated and steroid-sparing – all important attributes for patients with autoimmune disease who are often young and active,” said Noreen R. Henig, MD, Kezar’s Chief Medical Officer, in the press release. “Based on the strength of these results, we plan to continue developing zetomipzomib for patients with lupus nephritis, as well as evaluate development opportunities for systemic lupus erythematosus.”
Read the full press release here.
