Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia

EMPACTA is the first global phase III trial to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patientsThere was no statistical difference in mortality between patients who received Actemra/RoActemra or placeboRoche plans to share these results with health authorities, including the US FDABasel, 18 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.Summary of Key EMPACTA Clinical and Safety FindingsPrimary endpoint was met: patients with COVID-19 associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.Key secondary endpointsThe difference in time to hospital discharge or “ready for discharge” to day 28 was not significant (median (days): Actemra = 6; placebo (PBO) = 7.5; log-rank p-value = 0.2456; HR [95% CI] = 1.16 [0.90, 1.48])The difference in time to improvement in ordinal clinical status to day 28 was not significant (median (days): Actemra = 6; PBO = 7; log-rank p-value = 0.2597; HR  [95% CI] = 1.15 [0.90, 1.47])Time to clinical failure to day 28 was longer in the Actemra arm compared to the placebo arm (median (days): Actemra = not-estimable (NE); PBO = NE; log-rank p = 0.0217; HR [95% CI] = 0.55 [0.33, 0.92]). However, the difference cannot be considered statistically significant as other key secondary endpoints were not met.There was no statistical difference in mortality between patients who received Actemra or placebo by day 28 (Actemra = 10.4%; PBO = 8.6%, p-value = 0.5146, Difference [95% CI]: 2.0% [-5.2%, 7.8%].At day 28, incidence of infections was 10% and 11% in the Actemra/RoActemra and placebo arms, respectively, and the incidence of serious infections was 5.0% and 6.3% in the Actemra/RoActemra and placebo arms, respectively. The most common adverse events in patients who received Actemra/RoActemra were constipation (5.6%), anxiety (5.2%), and headache (3.2%). The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.Results from the EMPACTA trial will be submitted for publication in a peer-reviewed journal.Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, andEnsuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received 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 Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July, we added a Rapid Antibody Test, with SD Biosensor as distribution partner, to our portfolio, that allows the detection of antibodies against Covid-19 at the point of care. On 1 September we announced that we will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. We also intend to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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