Compelling phase III efficacy after only 6 pre-seasonal injections of Pollinex Quattro Grass

Abstract

Background

Pollinex Quattro (PQ) Grass 27600 SU cumulative dose is a short-course (6 pre-seasonal injections) modified subcutaneous grass immunotherapy product under development for the treatment of allergic rhinitis. RESONATE was the pivotal phase III randomized double-blind, placebo-controlled clinical trial performed to evaluate the efficacy and safety of PQ Grass.

Methods

RESONATE applied an adaptive group sequential trial design with 1 pre-defined interim analysis, conducted simultaneously in the United States and Europe. The primary efficacy endpoint was the “combined symptom” and “medication score” as proposed by the European Academy of Allergy and Clinical Immunology averaged over the peak grass pollen season.

Results

RESONATE could be stopped for success after the randomization of 555 subjects at the interim stage, as superiority in favor of PQ Grass compared with placebo was demonstrated. The primary endpoint combined symptom and medication score as proposed by the European Academy of Allergy and Clinical Immunology during peak grass pollen season showed a relative difference of −20.3% (95% CI: −31.00% to −9.49%, P = .0005). Highly consistent beneficial results were obtained for PQ Grass on all key secondary endpoints. Patients showing high compliance (>90%) received all 6 injections and, more than 95% completed the 6-month safety follow-up. The PQ Grass was well tolerated, and there were no unexpected safety signals.

Conclusion

This pivotal phase III trial demonstrated a significant and clinically meaningful effect on the primary endpoint. The study is pivotal and allows progress toward the application for registration of PQ Grass 27600 SU.