New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19
- Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days
- The 2,400 mg and 1,200 mg doses tested in the phase III study had similar efficacy across all endpoints
- Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab
- The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S. FDA1
Basel, 23 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non-hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab significantly reduced the risk of hospitalisation or death by 70% (1,200 mg intravenously [IV]) and 71% (2,400 mg IV) compared to placebo.
Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers). In addition, a companion phase II trial (REGN-COV 20145) in low risk symptomatic or asymptomatic non-hospitalised patients with COVID-19 showed significant and comparable viral load reductions across doses ranging from 300 to 2,400 mg.
“Today's results show the important medical benefit casirivimab and imdevimab may provide to people with COVID-19 by significantly reducing their risk of hospitalisation and death,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “New infections continue to rise globally with over three million reported cases last week, so this investigational antibody cocktail may offer hope as a potential new therapy to high-risk patients - particularly in light of recent evidence showing that casirivimab and imdevimab together retain activity against key emerging variants. Together with our partner Regeneron, we are grateful to the patients and investigators who have participated in ongoing clinical trials and look forward to discussing the growing body of evidence with health authorities and to bringing the treatment to as many people as possible."
In addition to these trials in non-hospitalised patients, the investigational antibody cocktail of casirivimab and imdevimab is currently being studied in a phase II/III clinical trial for the treatment of COVID-19 in hospitalised patients, the phase III open label RECOVERY trial of hospitalised patients in the UK, and a phase III trial for the prevention of COVID-19 in household contacts of infected individuals. As of March 2021, approximately more than 25,000 people have participated in casirivimab and imdevimab clinical trials.
Detailed results from both trials (REGN-COV 2067 and REGN-COV 20145) will be shared with regulatory authorities and submitted for peer review as soon as possible. Regeneron will share new data with the U.S. Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe. Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.