“The rationale behind the use of duvelisib is that the drug may be able to calm the systemic inflammation that exacerbates COVID-19-associated pneumonia and acute respiratory distress syndrome."
Duvelisib (Copiktra), an anticancer drug, is currently being explored as treatment to reduce lung inflammation in hospitalized patients with coronavirus disease 2019 (COVID-19) in an investigator-initiated phase 2 study at the Winship Cancer Institute of Emory University.
“The rationale behind the use of duvelisib is that the drug may be able to calm the systemic inflammation that exacerbates COVID-19-associated pneumonia and acute respiratory distress syndrome,” stated principal investigator Edmund K. Waller, MD, PhD, professor, Hematology and Medical Oncology, Medicine and Pathology, Emory University School of Medicine, holder of Rein Saral, MD Professorship in Cancer Medicine, and medical director, Center for Stem Cell Processing and Apheresis, Emory University Hospital.
Pre-clinical data suggests that the agent can mitigate T cell exhaustion. More research has demonstrated T cell exhaustion limits the effectiveness of the immune system in fighting the infection.
Waller’s lab has also previously tested whether duvelisib can enhance the activity of chimeric antigen receptor T-cell therapy in patients with cancer prior to the onset of the COVID-19 pandemic.
The phase 2 study will enroll 40 patients who are hospitalized with COVID-19-associated pneumonia. The trial is expected to last for 1 year. Every patient will receive either duvelisib or placebo for 2 weeks. Efficacy will be determined after 1 month. Patients will receive standard-of-care treatment and may receive antiviral medications, such as remdesivir (Veklury).
Waller is joined by co-investigators Aneesh K. Mehta, MD, and Marshall Lyon III, MD, infectious disease specialists, Emory Winship.
"This study is an example of how research on cancer immunology can be repurposed and deployed against COVID-19, possibly improving patient outcomes during this crisis," said Walter J. Curran, Jr, MD, the Lawrence W. Davis Chair, Radiation Oncology, Georgia Research Alliance Eminent Scholar, Chair in Cancer Research, and executive director, Winship, in a statement. "We are happy to be able to cooperate with our infectious disease and critical care colleagues in this effort."
The FDA previously granted approval to duvelisib in September 2018 for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Duvelisib can reduce levels of some of the same immune messenger cytokines that become elevated during a COVID-19 infection, according to previous data from patients with leukemia and lymphoma. In the phase 3 DUO trial (NCT02004522), the study in which the approval was based on, duvelisib reduced the risk of disease progression or death by 60% compared with ofatumumab (Arzerra) in patients with relapsed/refractory CLL/SLL who had received at least 2 prior lines of therapy.
Repurposing a cancer drug to reduce COVID-19 lung inflammation. News Release. July 13, 2020. Accessed July 16, 2020. https://bit.ly/2WpWrr2