Takeda reports Phase 3 AURORA trial did not meet primary endpoint

Takeda announced that in the AURORA trial, a Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of CMV infection in hematopoietic stem cell transplant, or HSCT, recipients, maribavir demonstrated clinically meaningful efficacy in confirmed CMV viremia clearance, but did not meet its primary endpoint of non-inferiority vs. valganciclovir based on the prespecified non-inferiority margin of 7%. The primary endpoint was defined as the proportion of patients who achieved confirmed CMV viremia clearance after exclusively maribavir compared to valganciclovir at end of treatment phase. At Week 16, the key secondary endpoint, 8 weeks after end of treatment, a numerically higher proportion of patients treated with maribavir maintained CMV viremia clearance and symptom control achieved at Week 8 compared to valganciclovir. This comparable maintenance of effect with maribavir was consistent at all post-treatment evaluations at Study Week 12 and Study Week 20. "Takeda is sharing the AURORA study results with relevant regulatory agencies and will continue to engage with them on a potential path forward for maribavir in asymptomatic first-episode post-transplant CMV infection. Full data results from the AURORA study will also be submitted for publication in a peer-reviewed journal," the company stated.