Phase III Trial Data Show Roche’s Xofluza Significantly Reduces Flu Transmission
Xofluza (baloxavir marboxil) met its primary endpoint in the CENTERSTONE trial, reducing the odds of untreated household members contracting influenza virus by 32%.
Roche has shared additional findings from the Phase III CENTERSTONE clinical trial of Xofluza (baloxavir marboxil). The study met its primary endpoint, with Xofluza demonstrating a 32% reduction in odds of untreated household members contracting influenza virus. These results are now published in the New England Journal of Medicine (NEJM).1
In the secondary endpoint of influenza virus transmission resulting in symptoms, the first-in-class, single-dose oral Xofluza showed a clinically meaningful reduction, but it did not achieve statistical significance. The therapy was well tolerated, with no new safety signals identified.
In a press release, Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said: “This trial is the first to demonstrate an antiviral effect that reduces transmission of influenza viruses within a household. This result may potentially have broad-reaching implications for public health. This publication (NEJM) reminds us of the ongoing societal need for solutions that can help ease the burden of influenza on society.”
As mentioned earlier, Xofluza met its primary endpoint. In comparison, placebo only reduced the odds of transmission by 13.4%, and the baloxavir arm saw a 9.5% reduction. For the key secondary endpoint of influenza virus transmission resulting in symptoms, Xofluza demonstrated a 25% reduction.
The Phase III CENTERSTONE trial (NCT03969212) was a global, randomized, placebo-controlled study. It evaluated single-dose Xofluza, taken within 48 hours of influenza virus symptom onset, to reduce the onward transmission within households. Over 4,000 participants including otherwise healthy patients from five to 64 years of age who had been diagnosed with influenza were enrolled in the trial across 272 sites.
Roche initially announced outcomes from CENTERSTONE in September 2024. According to the company, it marked the first time that any antiviral used in the treatment of a respiratory viral illness had demonstrated a transmission reduction benefit in a global Phase III trial.2
In a press release from the time, Garraway said: “Building on Xofluza’s established efficacy in treating and preventing influenza after exposure, this new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level. We look forward to discussing these data with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients.”
References
1. New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission. News release. Roche. April 24, 2025. Accessed April 25, 2025. https://www.roche.com/media/releases/med-cor-2025-04-25
2. Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses. News release. Roche. September 18, 2024. Accessed April 25, 2025. https://www.roche.com/media/releases/med-cor-2024-09-19
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