- Among individuals who still experienced symptomatic infections, those who received casirivimab and imdevimab were able to clear the virus faster and had much shorter symptom duration
- In a cohort of recently-infected asymptomatic patients, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%
- Detailed results will be shared with regulatory authorities including the EMA and the FDA
“Today’s data confirm the potential dual value of casirivimab and imdevimab to reduce household COVID-19 infections and to decrease the disease burden in those who do become infected, when given as a subcutaneous option,” said
The phase III, double-blind, placebo-controlled trial assessed the effect of casirivimab and imdevimab on individuals without SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. It included 1,505 people who were not infected with SARS-CoV-2 at baseline and received either one dose of casirivimab with imdevimab (1,200 mg) or placebo, administered as subcutaneous injections.
In addition, the multi-part study evaluated the antibody cocktail in a cohort of 204 recently infected asymptomatic patients randomised to receive either one dose of casirivimab and imdevimab (1,200 mg subcutaneous administration) or placebo. In this cohort, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%.
Detailed results from the trial will be shared with regulatory authorities as soon as possible. Regeneron will share new data with the
The antibody cocktail continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the
In these exceptional times,
Table 1: Key results from phase III prevention cohort in uninfected individuals*
Casirivimab and imdevimab (1,200 mg subcutaneous dose) | Placebo | |
n=753 | n=752 | |
Proportion of subjects with symptomatic SARS-CoV-2 infections through day 29 (primary endpoint) | ||
Risk reduction | 81% (p<0.0001) | |
# of patients with events | 11 (1.5%) | 59 (7.8%) |
Symptoms and viral load | ||
Total weeks with symptoms | ||
Reduction | 93% (p<0.0001) | |
Total # of weeks (cumulative for all individuals in each arm) | 13 | 188 |
# of weeks with symptoms (mean) in symptomatic individuals | 1.2 | 3.2 |
Total weeks with high viral load (>104 copies/mL) | ||
Reduction | 90% (p<0.0001) | |
Total # of weeks (cumulative for all individuals in each arm) | 14 | 136 |
# of weeks with high viral load (mean) in qPCR positive subjects | 0.4 | 1.3 |
*Individuals without any COVID-19 symptoms who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. Based on the seronegative modified Full Analysis Set population, which includes all randomized subjects without evidence of current or prior SARS-CoV-2 infection (i.e., a negative RT-qPCR test and a negative antibody test) at randomization.
Adverse events (AEs) occurred in 20% (n=265 out of 1,311) of REGEN-COV participants and 29% (n=379 out of 1,306) of placebo participants, and serious AEs occurred in 1% (n=10) of REGEN-COV participants and 1% (n=15) of placebo participants. There were 0 REGEN-COV participants and 4 placebo participants who were either hospitalized or visited the emergency room because of COVID-19 during the 29-day efficacy assessment period. Injection site reactions, all of which were grades 1-2, occurred in 4% (n=55) of REGEN-COV participants and 2% (n=19) of placebo participants. No individuals from either group withdrew from the trial due to AEs, and none of the deaths in the trial (2 REGEN-COV, 2 placebo) were attributed to COVID-19 or study drug.
Table 2: Key results from phase III treatment cohort in asymptomatic infected individuals
Casirivimab and imdevimab (single 1,200 mg dose) | Placebo | |
n=100 | n=104 | |
Proportion of subjects with symptomatic SARS-CoV-2 infections through day 29 (primary endpoint) | ||
Risk reduction | 31% (p=0.0380) | |
# of patients with events (cumulative for all individuals in each arm) | 29 (29%) | 44 (42%) |
Symptoms, viral load and COVID-19 related events | ||
Total weeks with symptoms | ||
Reduction | 45% (p=0.0273) | |
Total # of weeks (cumulative for all individuals in each arm) | 90 | 170 |
Total weeks with high viral load (>104 copies/mL) | ||
Reduction | 40% (p=0.001) | |
Total # of weeks | 48 | 82 |
Based on the seronegative modified Full Analysis Set population, which includes all randomized asymptomatic patients who were SARS-CoV-2 positive but had no evidence of prior infection (i.e., a positive RT-qPCR test and a negative antibody test) at randomization
Adverse events (AEs) occurred in 34% (n=52 out of 155) of REGEN-COV patients and 48% (n=75 out of 156) of placebo patients, and serious AEs occurred in 0% (n=0) of REGEN-COV patients and 3% (n=4) of placebo patients. Injection site reactions, all of which were grades 1-2, occurred in 4% (n=6) of REGEN-COV patients and 1% (n=1) of placebo patients. No patients from either group withdrew from the trial due to AEs, and there were no deaths.
About REGN-COV 2069
REGN-COV 2069 is a phase III, randomised, double-blind, placebo-controlled multi-part study assessing the efficacy and safety of casirivimab and imdevimab in preventing symptomatic infection in household contacts of individuals infected with COVID-19.
In
In the safety assessment of these patients, adverse events occurred more frequently in participants on placebo during the efficacy analysis period (12% in the casirivimab and imdevimab group and 18% in the placebo group) and during the follow-up period (11% in the casirivimab and imdevimab group and 20% in the placebo group).
About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The two potent, virus-neutralising antibodies casirivimab and imdevimab are believed to bind non-competitively to the critical receptor binding domain of the virus's spike protein, which is hypothesised to diminish the ability of mutant viruses to escape treatment and to protect against spike variants that may arise in the human population, as detailed in Science publications.
The cocktail of casirivimab and imdevimab has not been granted a marketing authorisation by any health authority. In
In
Casirivimab and imdevimab’s development, manufacturing and clinical trials have been funded in part by the
About
Casirivimab and imdevimab have not been
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems. We also continue to identify, develop and support potential therapies which can play a role in treating the disease.
The impact of COVID-19 goes beyond those who contract it. That is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure patients continue to receive the tests, treatment and care they need during these challenging times. Building on a longstanding tradition of partnerships, we are working together with governments and others to make healthcare stronger and more sustainable in the future.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic and
Aside from these tests we have also looked at how we can support care for patients who have COVID-19, receiving an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching
In October,
In November, our partner Regeneron received FDA EUA for casirivimab and imdevimab, its investigational antiviral antibody combination, for the treatment of recently diagnosed patients with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19 and/or hospitalisation. The antibody cocktail is currently being studied in two phase I-III adaptive clinical trials for the treatment of COVID-19 and in a phase III trial for the prevention of the disease. As part of the global partnership with Regeneron, we are committing a significant amount of manufacturing capacity and are working to expand supply of this antibody combination beyond the US to as many people as possible.
In addition, we are exploring the potential of our investigational molecules and existing portfolio: For example,
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Attachment
- 12042021_MR_2069 phase III data of casivrimib and imdevimab_EN
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