June 8, 2022

expert reaction to results of the TACKLE Phase 3 trial of Evusheld (tixagevimab and cilgavimab) for treating early COVID-19 in outpatients

Results of a phase 3 trial published in The Lancet Respiratory Medicine look at safety and efficacy of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19.

Prof Penny Ward, Independent Pharmaceutical Physician, and Visiting Professor in Pharmaceutical Medicine at King’s College London, said:

“Welcome data today with the publication of the outcomes of TACKLE, the study investigating the therapeutic efficacy of Evusheld in early treatment of mild-moderate COVID in patients at higher risk of disease progression. As previously reported, a single intramuscular (IM) injection of 600mg Evusheld reduced the need for hospitalisation/death due to COVID by at least 50% with increased protection conferred with treatment instituted faster after first onset of symptoms. This product is a long acting antibody combination and can confer longer lasting protection against re-infection in recipients. Although this study was conducted in an unvaccinated population at the time that the alpha and delta variants were the predominant strains, this antibody combination has been shown to have retained activity against the various Omicron strains currently circulating in the UK. The IM route of administration of Evusheld is also less resource intensive than intravenous (IV) infusion and facilitates easier use in the community than products requiring IV infusion. Only one antibody treatment is currently in use in the UK – sotrovimab. However this agent has been shown in vitro to be ineffective against the BA.2 omicron variant and was withdrawn from clinical use in the USA in February. Now that we have complete data on the therapeutic effectiveness of Evusheld and documented that it retains activity against currently circulating omicron variants, perhaps the time has come to consider adding Evusheld to the list of therapies for clinical use for the treatment of COVID in the UK.”

‘Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial’ by Hugh Montgomery et al is published in The Lancet Respiratory Medicine

DOI: https://doi.org/10.1016/S2213-2600(22)00180-1 

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Penny Ward: “I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”

No others received.