Roche’s Arthritis Drug Fails in Phase III COVID-19 Treatment Study

July 29, 2020 - Roche recently announced that the Phase III COVACTA trial of its rheumatoid arthritis (RA) drug, Actemra/RoActemra, did not meet its primary endpoint of improved clinical status in patients with severe COVID-19 associated pneumonia. 

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The late-stage stage also found that the drug did not meet key secondary endpoints, which included the difference in patient mortality at week four. 

Specifically, rates of infection at this time were 38.3 percent in the Actemra/RoActemra group and 40.6 percent in the placebo group. Additionally, the rates of serious infections were 21 percent and 25.9 percent for the Actemra/RoActemra and placebo groups, respectively. 

However, researchers found a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra.

The median time to discharge for Actemra/RoActemra was 20 days. For the placebo group, it was 28 days. 

But researchers noted that this difference cannot be considered statistically different because the primary endpoint was not met. 

There was no significant difference in ventilator-free days between patients treated with Actemra/RoActemra (22 days) and patients treated with placebo (16.5 days). 

The study did not identify any new safety signals for Actemra/RoActemra.

“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in the announcement.

“We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”

Actemra/RoActemra was the first approved biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis, Roche explained.

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to determine if the arthritis drug could work as a COVID-19 treatment for hospitalized patients.. 

Back in mid-March, Roche announced the initiation of the COVACTA trial to uncover the safety and efficacy of Actemra/RoActemra plus standard care in hospitalized adult patients with COVID-19 pneumonia. 

The clinical trial goal was to find clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.

Although not currently approved by FDA, Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020. 

In addition to the COVACTA trial, Roche has launched other studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia.

These trials include two Phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial.

The Remdacta trial is currently evaluating the safety and efficiency of Actemra/RoActemra plus antiviral remdesivir, versus placebo plus remdesivir in patients with severe COVID-19 pneumonia. 

“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” Garraway said in the announcement.

"Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We're pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”

The study began enrolling nearly 450 patients in mid-June with study results expected sometime in the near future.