In a significant development, Roche has said that its advanced Phase-III COVACTA study of Tocilizumab did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe Covid-19 associated pneumonia.
The company also said that key secondary endpoints, which included the difference in patient mortality at week four, were not met. However, there was a positive trend in hospital discharge time in patients treated with Tocilizumab, sold under the brandnames Actemra/RoActemra.
Roche’s latest announcement will have ramifications in India as well, as drugmaker Cipla has an alliance with the multinational and sells the drug in India. Many hospitals have been using the drug to treat Covid-19 patients.
The COVACTA study did not identify any new safety signals for Tocilizumab, the company said. “Further analysis of the trial results is needed to fully understand the data,” the company said, adding that the results would be submitted for publication in a peer-reviewed journal.
“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,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
“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.”
The COVACTA trial is the first global, randomised, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalised with severe Covid-19 associated pneumonia, with study locations in the US, Canada and Europe.
The trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of care treatment compared to treatment with placebo plus standard of care.
The primary endpoint of clinical status in hospitalised adult patients with severe Covid-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements.