Roche’s Actemra/RoActemra (tocilizumab) has failed to achieve the primary endpoint in the phase III trial, which included hospitalised patients with severe Covid-19 associated pneumonia.
The phase III COVACTA study of tocilizumab did not reach its primary endpoint of improved clinical status in hospitalised adult patients with severe Covid-19 associated pneumonia.
Roche’s trial has also failed to meet crucial secondary endpoints, including the difference in patient mortality at week four. The study has failed to detect any new safety signals for Actemra/RoActemra.
The trial was carried out 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 is a global, randomised, double-blind, placebo-controlled phase III study designed to assess the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe Covid-19 associated pneumonia compared to placebo plus standard of care.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables at week four. The company will follow the patients for 60 days post randomisation.
Roche chief medical officer and global product development head Dr 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.
“We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in Covid-19 associated pneumonia.”
Roche has commenced various several studies to further evaluate Actemra/RoActemra as a potential treatment for patients with Covid-19 associated pneumonia, including two phase III clinical trials such as REMDACTA and EMPACTA as well as the phase II MARIPOSA trial.
Actemra/RoActemra is said to be the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations to treat adult patients with moderate-to-severe active rheumatoid arthritis (RA).
Recently, Jnana Therapeutics signed a multi-target collaboration and license deal worth over $1bn with Roche for the discovery of small molecule drugs for the treatment of immune-mediated and neurological diseases.