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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 patients
  • There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo
  • Roche plans to share these results with health authorities, including the US FDA

Basel, 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.

“The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia, an important outcome in this serious disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to share this important data with the US Food and Drug Administration (FDA) and other health authorities around the world.”

The study is the first global, phase III COVID-19 clinical trial to primarily enrol patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups.

The majority of patients were Hispanic, with significant representation of Native American and Black populations. The trial was conducted in the United States, South Africa, Kenya, Brazil, Mexico and Peru. “We have been striving to improve inclusion and diversity in our trials,” said Jamie Freedman, M.D., Ph.D., Head of U.S. Medical Affairs. “During the COVID-19 pandemic, we saw how high the stakes were for many communities of colour and made diversity the centerpiece of this trial.”

The EMPACTA trial builds on Roche’s work in Advancing Inclusive Research, a cross-organisational US initiative to help address barriers in clinical research for underrepresented racial and ethnic groups.

Summary of Key EMPACTA Clinical and Safety Findings
Primary 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 endpoints
      • The 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.

Actemra/RoActemra is currently being investigated as a potential treatment for COVID-19 associated
pneumonia, including in combination with an antiviral in the phase III REMDACTA clinical trial. Results
from the phase III COVACTA trial in patients with severe COVID-19 associated pneumonia were released in
July. In addition, there are a number of independent trials of Actemra/RoActemra in this setting.
Actemra/RoActemra has not been approved by any health authority for COVID-19 associated pneumonia.

For more information on how Roche is responding to the global COVID-19 pandemic, please visit our
COVID-19 response page.

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