ROCHE HOLDING AG 
-- 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
Basel, 12 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
confirmed positive results from the phase III REGN-COV 2069 trial
assessing the ability of the investigational antibody cocktail
casirivimab and imdevimab to reduce the risk and burden of COVID-19
infection among household contacts of SARS-CoV-2 infected individuals.
The trial, which was jointly run with the National Institute of Allergy
and Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), met its primary and key secondary endpoints. It showed
that the subcutaneous administration of casirivimab and imdevimab
reduced the risk of symptomatic infections by 81% in those who were not
infected when they entered the trial. In addition, individuals treated
with casirivimab and imdevimab who still experienced a symptomatic
infection resolved their symptoms on average within one week, compared
to three weeks with placebo. No new or serious safety signals were
observed.
"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 Levi Garraway, M.D., Ph.D., Roche's Chief
Medical Officer and Head of Global Product Development. "Although
vaccinations are increasing globally, there remains a critical unmet
need worldwide to prevent infections and provide immediate protection
from COVID-19 between close contacts. This is why we are excited to
bring this data to health authorities with the goal of making the
combination available to more people as soon as possible."
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
United States (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.
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 UK. As of April 2021, more than 25,000
people have participated in clinical trials involving casirivimab and
imdevimab.
In these exceptional times, Roche stands together with society,
governments, healthcare providers and all those working to overcome the
pandemic.
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)
---------------------------------------------------------------------------
81%
Risk reduction (p<0.0001)
--------------------------------------- ----------------------------------
# of patients with events 11 (1.5%) 59 (7.8%)
--------------------------------------- ----------------------- ---------
Symptoms and viral load
---------------------------------------------------------------------------
Total weeks with symptoms
---------------------------------------------------------------------------
93%
Reduction (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 (>10(4) copies/mL)
---------------------------------------------------------------------------
90%
Reduction (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)
--------------------------------------------------------------------------
31%
Risk reduction (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
--------------------------------------------------------------------------
45%
Reduction (p=0.0273)
------------------------------------------- -----------------------------
Total # of weeks (cumulative for
all individuals in each arm) 90 170
------------------------------------------- ------------------- --------
Total weeks with high viral load (>10(4) copies/mL)
--------------------------------------------------------------------------
40%
Reduction (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 (MORE TO FOLLOW) Dow Jones Newswires
April 12, 2021 01:00 ET (05:00 GMT)
