Tocilizumab and Remdesivir Trial for COVID-19
A phase III study is now open to study the COVID-19 therapies of tocilizumab alone or with remdesivir for hospitalized patients with severe COVID-19 pneumonia. Remdesivir has been issued an Emergency Use Authorization by the FDA for the treatment of hospitalized patients with severe COVID-19. Many myeloma patients may be familiar with the fact that tocilizumab can be used to quiet the cytokine release syndrome common with CAR T therapy.
“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech. "Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We're pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”
The study is expected to begin enrolling in June with a target of approximately 450 patients globally.
The comppany is also almost finished enrolling patients in the Phase III clinical trial comparing tocilizumab vs. no treatment for severe COVID-19 symptoms. There will be 450 patients included in this study and the study data is expected this summer. This study is being conduced with the FDA and the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). Genentech is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH) and the Foundation of the NIH.
Genentech has also opened a 375-patient COVID-19 trial that will focus on underserved and miniority poopulations who might not otherwise have access to clinical trials.