AstraZeneca has announced detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo.
There were no cases of severe disease or COVID-19 related deaths in the Evusheld group through the six-month follow-up, the company noted.
More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have an inadequate immune response to vaccination.
Additional pharmacokinetic data showed that Evusheld concentrations remained elevated in serum for six months after administration, supporting that a single dose could provide long-term protection against COVID-19 lasting at least six months.
The company published data on New England Journal of Medicine.
Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and PROVENT principal investigator on the trial, said: “While COVID-19 vaccines have been highly effective at reducing hospitalisation and death, cases continue to surge and many individuals remain at high risk, including immunocompromised individuals and those who cannot be vaccinated. These important data now published in the New England Journal of Medicine provide confidence that one easily administered intramuscular dose of Evusheld could provide vulnerable populations long-lasting protection. In addition, Evusheld has been shown to neutralise BA.2, currently the dominant circulating COVID-19 variant.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said:”These data add to the growing body of evidence supporting the use of Evusheld to help prevent symptomatic and severe COVID-19, especially for those individuals who can’t respond adequately to vaccination and need additional protection. Evusheld is now available in many countries around the world, and we are progressing filings in pre-exposure prophylaxis as well as mild-to-moderate treatment.”
Company also noted that Evusheld was generally well tolerated in PROVENT, and no safety issues were identified at either the primary or six-month analysis. Adverse events accrued at similar rates in the Evusheld and placebo groups. The most common adverse event was injection-site reaction, occurring in 2.4% of participants in the Evusheld group and 2.1% of participants in the placebo group.
Approximately 2% of the global population is considered at increased risk of an inadequate response to COVID-19 vaccination and may particularly benefit from pre-exposure prophylaxis with Evusheld. This population includes people who are immunocompromised, such as those with cancer or transplant patients or anyone taking immunosuppressive medicines. People at increased risk of exposure to the SARS-CoV-2 virus could also benefit from protection with Evusheld.
AstraZeneca previously announced positive high-level results from the TACKLE Phase III trial in the treatment of mild-to-moderate COVID-19.
Evusheld, formerly known as AZD7442, is a combination of two long-acting antibodies – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by individuals previously infected with the SARS-CoV-2 virus. Evusheld has marketing authorisation in the European Union and was granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19. Evusheld is authorised for emergency use for pre-exposure prophylaxis of COVID-19 in the US. Evusheld is also authorised for use and being supplied in several other countries around the world. Regulatory filings are progressing in both prevention and treatment around the world.