Roche recently announce the launch of a global study in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. TrialSite News has reports that the global giant has signed up its first patient achieving the important study milestone first-patient-first- visit in record time in Spain. Although a large and multifaceted multinational corporation with nearly 100,000 employees, Roche appears to be responding to COVID-19 in an agile, adaptive and targeted manner evidencing impressive leadership and effective organizational readiness for what is in reality an unprecedented situation.
The Study Drug
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). The drug can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDS). In Europe, RoActemra IV and SC are approved for use in patients with severe, active and progressive RA who previously have not been treated with MTX.
In the U.S. and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell induced severe or life-threatening cytokine release syndrome (CRS) in people with two years of age and older. It was the first approved treatment of CRS in this setting. A prefilled autoinjector, ACTPen has been approved in the US and Europe. In Japan, the drug is approved for the treatment of Castleman’s Disease and Takayasu Arteritis. The drug is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since 2005. The drug is approved in more than 110 countries worldwide.
The first global study of Actemra/RoActemra in this setting has commenced, targeting approximately 330 patients globally, including America. The Swiss industry sponsor, one of the largest pharma companies on the planet, seeks primary and secondary endpoints including clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
The Phase III clinical trial, known as COVACTA, evaluates the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard care. The sponsor seeks to understand primary and secondary endpoints such as clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables. Participating patients will be followed for 60 days post randomization and an interim analysis will be conducted to look for early evidence of efficacy.
Levi Garraway, Chief Medical Officer and Head of Global Product Development noted recently that they were “initiating a clinical trial to study Actemra/RoActemra for the treatment of hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease.” Garraway went on to comment on how the company has been able to organize and collaborate with regulators rapidly to deal with the onslaught of the COVID-19 pandemic.