Genentech, a Member of the Roche Group, said today it is launching a Phase III trial to assess its marketed arthritis drug Actemra® (tocilizumab) as a treatment for adults with severe COVID-19.
Genentech said it is working with the FDA and the Biomedical Advanced Research and Development Authority (BARDA) on the randomized, double-blind, placebo-controlled trial, named COVACTA. The trial will evaluate the safety and efficacy of intravenous Actemra plus standard of care in hospitalized adults with severe COVID-19 pneumonia, compared to placebo plus standard of care.
The trial will seek to enroll approximately 330 patients worldwide, including the U.S., with recruitment of patients set to begin in early April.
The trial’s primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy, Genentech said.
“We are initiating a clinical trial to study Actemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra in fighting this disease,” Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development, said in a statement. “In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
First approved in 2010
Actemra was approved by the FDA in 2010 as the first interleukin-6 (IL-6) receptor antagonist authorized for moderately to severely active rheumatoid arthritis (RA) patients who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. In addition, Actemra is approved for adults with giant cell arteritis, and for patients aged 2 years old and older with polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and CAR T cell-induced cytokine release syndrome.
Actemra is one of two IL-6 receptor antagonists being studied as potential COVID-19 treatments. The other is Kevzara® (sarilumab) co-developed by Regeneron Pharmaceuticals and Sanofi—which on March 16 announced that they launched a Phase II/III clinical program of up to 400 patients assessing the drug in severe COVID-19 coronavirus infection.
The FDA on March 13 also granted the company Emergency Use Authorization for use of Roche Diagnostics’ cobas® SARS-CoV-2 Test to detect the virus that causes COVID-19 disease.
The COVACTA study is one of several clinical trials evaluating Actemra worldwide. On March 3, China’s National Health Commission (NHC) included Actemra in its 7th updated diagnosis and treatment plan for COVID-19.
Trials in China, Italy
Actemra is under study as a COVID-19 treatment in two active Chinese clinical studies, according to the Chinese Clinical Trials Registry:
- A 150-patient trial assessing Actemra in combination with favipiravir, a broad spectrum anti-viral agent (ChiCTR2000030894), led by Hong Zhao of Peking University First Hospital. In China, Actemra is marketed as tocilizumab by Roche-owned Chugai Pharmaceutical while favipiravir is sold by Zhejiang Hisun Pharmaceutical; Fujifilm markets that drug in the U.S. as Avigan®.
- A 188-patient trial assessing Actemra alone (ChiCTR2000029765), led by Dongsheng Wang of The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital).
A third clinical trial assessing Actemra in COVID-19 has been canceled as of March 14 by its investigator. In that 100-patient study (ChiCTR2000030442), registered on March 2, Ma Xiaorong, PhD, of the Second Affiliated hospital of Xi’an Jiaotong University would have led a study team in evaluating Actemra in combination with intravenous immunoglobulin (IVIG) and Continuous Renal Replacement Therapies (CRRT) in patients with severe COVID-19 pneumonia.
In Italy, Actemra is the subject of an up-to-30-patient Phase II trial (NCT04315480) designed to study the drug as a single 8mg/Kg dose in patients affected by severe pneumonia correlated to SARS-CoV2. The study by researchers at Università Politecnica delle Marche and Azienda Ospedaliera Ospedali Riuniti Marche Nord has two primary outcome measures: arrest in deterioration of pulmonary function, and improvement in pulmonary function.
Just last week, Genentech disclosed that it was in “active discussions” with the FDA and other government agencies and institutions worldwide to initiate clinical trials for Actemra.
Actemra is one of 60 treatments highlighted by GEN in its new updated A-List of COVID-19 therapies in the works, Catching Up to Coronavirus: Top 60 Treatments in Development.