A Multinational Phase III Study of CS-8958 (MARVEL)

Summary

The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures. In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.

Timeline

Start

2008-11

Primary completion

2009-03

Completion

2009-06

Outcome

Met primary endpoint

paper The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). PMID 20936975 ↗

registry CS-8958 High Dose 40 mg vs CS-8958 Low Dose 20 mg; p = 0.038; Median Difference (Final Values) -12.8 (95% CI -18.2 to -0.4) NCT00803595 ↗

release “In the Phase III trials conducted by Daiichi Sankyo, a single inhaled dose of CS-8958 was shown to be as effective as oseltamivir” hovione.com ↗

release “non-inferiority to oseltamivir phosphate was confirmed in both the 20 mg group and 40 mg group of CS-8958 in terms of the primary endpoint” daiichisankyo.com ↗

Publications

• Watanabe A, Chang SC, Kim MJ, Chu DW, Ohashi Y; MARVEL Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010 Nov 15;51(10):1167-75. doi: 10.1086/656802. Epub 2010 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Laninamivir Octanoate	Small molecule	20 mg	Inhaled
Subject	Laninamivir Octanoate	Small molecule	40 mg	Inhaled
Comparator	Oseltamivir	Small molecule	75 mg	Oral

Indications