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July 29, 2020updated 21 Oct 2021 11:46am

Roche’s Actemra fails to meet Phase III goals in Covid-19 patients

Roche has reported that its Actemra/RoActemra (tocilizumab) drug failed to meet the primary endpoint of improved clinical status in the Phase III COVACTA trial involving hospitalised adults with severe Covid-19-related pneumonia.

Roche has reported that its Actemra/RoActemra (tocilizumab) drug failed to meet the primary endpoint of improved clinical status in the Phase III COVACTA trial involving hospitalised adults with severe Covid-19-related pneumonia.

The key secondary endpoints, including the difference in patient mortality at week four, were also not met.

However, data showed a positive trend in time to hospital discharge. It also revealed no new safety signals for Actemra/RoActemra.

The difference in ventilator-free days between Roche’s drug and placebo was not statistically significant.

At week four, rates of infections in the Actemra and placebo arms were 38.3% and 40.6%, respectively, while the rates of serious infections were 21% and 25.9%, respectively.

Roche chief medical officer and Global Product Development head Levi Garraway 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.

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“We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in Covid-19 associated pneumonia.”

The randomised, double-blind, placebo-controlled Phase III trial was performed in alliance with the US Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

It assessed the safety and efficacy of Actemra in combination with standard of care compared to placebo at clinical sites across the US, Canada, and Europe.

Actemra is an anti-IL-6 receptor biologic indicated to treat adults with moderate to severe active rheumatoid arthritis (RA).

Apart from COVACTA, the company is conducting multiple studies to evaluate Actemra for the treatment of Covid-19 associated pneumonia, including Phase III REMDACTA and EMPACTA trials, and the Phase II MARIPOSA study.

Several independent trials of the drug are ongoing in this indication.

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