Abstract PO-092: Expanded access trial of tocilizumab in COVID19+ hospitalized cancer patients
Authors: Shah Nirali N. , Ivy Percy , Enos Rebecca , Boron Matthew J. , Howells Rodney , Freidlin Boris , Allegra Carmen , Mooney Margaret M. , McCaskill-Stevens Worta , Doroshow James H. , Little Richard F. 
Published: December 2020

Abstract
Introduction: Emerging data from the COVID-19 pandemic suggest that an IL6-mediated cytokine release syndrome (CRS) may contribute to disease severity. Tocilizumab (Toci), an anti-IL6 receptor antibody, is FDA approved for the treatment of chimeric antigen receptor T cell-associated CRS for patients (pts) as young as 2 years of age. Phase 3 randomized testing of toci in pts with severe COVID-19 disease is ongoing. Cancer pts infected with SARS-CoV-2 are at risk for life-threatening or fatal complications. Outcomes are particularly dismal for those with hematologic malignancies or lung cancer. Due to disease and treatment-related complications, cancer patients may not be eligible for enrollment on COVID-19 directed studies, including the aforementioned randomized phase 3 study of toci. Furthermore, access to clinical trials is frequently restricted to those who are adults; however, children with cancer may also be predisposed to developing more severe complications from COVID-19. Improving access to clinical trial enrollment for vulnerable, minority, and underserved populations at increased risk of complications from COVID-19 is imperative.
Methods: We developed a multicenter, single-arm, open-label, expanded-access treatment study to provide toci to cancer pts with COVID-19. Coordinated through the National Cancer Institute, Cancer Therapy Evaluation Program, and the Division of Cancer Treatment and Diagnosis, this expanded-access trial is being conducted to provide clinical trial access to this potentially beneficial therapy in cancer pts and to collect data on clinical outcomes. The primary objective is to enhance access to toci for cancer patients who cannot participate in the randomized phase 3 toci trial with a specific emphasis on enrollment of those who belong to high-risk and minority populations and children. Hospitalized cancer subjects &gt; 2 years of age with COVID-19 respiratory compromise may be eligible to receive toci. Treatment will allow for up to two doses of toci and will also evaluate the efficacy of a lower dose of toci in those who are not intubated. Concurrent receipt of investigational cancer and/or antiviral therapy and other supportive therapies is permitted. Exploratory objectives will include analysis of inflammatory cytokines, monitoring of SARS-CoV-2 viral load, and determination of pharmacokinetics of toci to facilitate exposure-response analysis.
Results: This trial was officially activated on May 28, 2020, and is being opened at multiple sites across the United States from the National Cancer Institute’s Community Oncology Research Program, the National Clinical Trials Network, and the Experimental Therapeutics Clinical Trials Network. Updates will be presented at the AACR Virtual Meeting: COVID-19 and Cancer.
Conclusions: Targeting an unmet need, this trial provides a prospective mechanism for tocilizumab access and clinical outcome collection in cancer patients with severe COVID-19 disease.
Citation Format: Nirali N. Shah, Percy Ivy, Rebecca Enos, Matthew J. Boron, Rodney Howells, Boris Freidlin, Carmen Allegra, Margaret M. Mooney, Worta McCaskill-Stevens, James H. Doroshow, Richard F. Little. Expanded access trial of tocilizumab in COVID19+ hospitalized cancer patients [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-092.