Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial.
Randomized trial evaluates zopa efficacy in achieving durable responses in adults with recurrent respiratory papillomatosis, suggesting a new treatment standard.
Key Points
This research aims to evaluate the efficacy and safety of zopapogene imadenovec-drba (zopa) in treating recurrent respiratory papillomatosis (RRP).
Pivotal trial (NCT04724980) with 35 patients requiring ≥3 interventions in the past year.
Patients received 4 subcutaneous injections of zopa (5x10^11 particle units).
12-month follow-up data were analyzed for safety and efficacy outcomes.
51% of patients achieved a complete response (CR) with no interventions required within 12 months (95% CI: 34 to 69).
83% of patients who achieved CR at 12 months maintained CR with no recurrence during 36 months of follow-up.
Safety profile remained excellent with no serious adverse events or new safety concerns observed.