Tocilizumab shows no benefits to patients in clinical status or mortality: Roche

PT Jyothi Datta Mumbai | Updated on July 29, 2020

More trials underway in other treatment settings and with an antiviral

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-associated pneumonia.

The company also said that key secondary endpoints, which included the difference in patient mortality at week four, were not met; though there was a positive trend in time to hospital discharge in patients treated with Tocilizumab, also sold under the brandnames Actemra/RoActemra.

Repercussions in India

Roche’s latest announcement will have ramifications in India, as drugmaker Cipla has an alliance with the multinational and sells the drug in India. Many doctors have been using this investigational therapy to treat Covid-19 patients, as it is part of the treatment protocol.

In fact, recently drug regulatory authorities in India had even busted black-marketeers who preyed on patients’ desperation for the drug.

Responding to a query from BusinessLine, Roche said, “While the COVACTA trial did not meet its primary or secondary endpoints, further analysis of the trial results is needed to fully understand the data and the results will be submitted for publication in a peer-reviewed journal.”

The company added that it was committed to continuing the Tocilizumab clinical trial programme in Covid-19 “to further explore Tocilizumab in other treatment settings, including in combination with an antiviral.”

Roche clarified that Tocilizumab was not an approved treatment for Covid-19 and “as such is not promoted by Roche for this use.”

Meanwhile, Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development said, “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.”

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-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.

Published on July 29, 2020

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