Meta-analysis of primary endpoint of Grass MATA MPL field studies with optimized dose and treatment regimen of PQ Grass 27600 SU

Rationale: PQ Grass 27600 SU is a modified broad spectrum grass allergen subcutaneous immunotherapy (SCIT) product using MicroCrystalline Tyrosine (MCT) and Monophosphoryl Lipid A (MPL) as adjuvant system. Two highly comparable randomised double-blind, placebo-controlled field studies with PQ Grass 27600 SU have been recently completed to support a marketing authorisation application. Here, we report on the integrated primary endpoint results using a meta-analysis approach.

Methods: A common effects meta-analysis was applied and justified due to the similarity of study designs, study populations, primary endpoint definitions (i.e. the EAACI recommended combined symptom and medication score (CSMS)) and statistical analysis methods. These were the only 2 field studies performed with the same optimized cumulative dose of PQ Grass 27600 SU, both conducted simultaneously in the EU and US to evaluate efficacy and safety of PQ Grass 27600 SU in patients (18 to 65 years of age inclusive) with seasonal allergic rhinitis ascribed to grass pollen exposure.

Results: In total 674 subjects with allergic conjunctivitis and/or rhinitis were included in this meta-analysis. The homogeneity of the data for the meta-analysis approach was also statistically confirmed (heterogeneity test p=0.21). The results of this meta-analysis showed a clinically relevant and highly statistically significant treatment effect for the primary endpoint CSMS during the peak grass pollen season (P-GPS).

Conclusions: PQ Grass 27600 SU is an innovative short-course allergen-specific SCIT product applying a potent adjuvant system. The two field studies with PQ Grass 27600 SU included in the meta-analysis were highly comparable and demonstrated a clinically relevant and statistically significant integrated primary endpoint result, supporting the marketing authorisation application of PQ Grass 27600 SU.

Publication History

Article published online:
18 March 2025