Researchers with The U.S. Oncology Network discovered AstraZeneca’s Calquence (acalabrutinib) benefited a small number of patients who have severe infections of the novel coronavirus.
Research on the usage of Calquence in the treatment of COVID-19 is in progress.
An oncology drug could prove to be effective against COVID-19. Researchers with The U.S. Oncology Network discovered AstraZeneca’s Calquence (acalabrutinib) benefited a small number of patients who have severe infections of the novel coronavirus.
Preliminary research conducted by the Network, AstraZeneca and the National Institutes of Science, showed that patients with acute respiratory distress syndrome (ARDS) from COVID-19 demonstrated measurable improvements in oxygenation. The study was conducted on 19 patients who were treated with the oncology drug for up to two weeks. Most patients who received Calquence, a Bruton Tyrosine Kinase (BTK) Inhibitor, saw measurable improvements in their oxygen levels within one to three days, the researchers said. Nine out of 11 patients, 82%, who had been receiving supplemental oxygen when treated with acalabrutinib were discharged from the hospital and no longer required supplemental oxygen. Additionally, 50% of the patients who were receiving mechanical ventilation prior to treatment were extubated and discharged without the need of supplemental oxygen.
The research, which was published in the journal Science Immunology, found that there were no observed toxicities attributable to acalabrutinib, including those outlined in the product’s important safety information, such as cardiac arrhythmia, bleeding, diarrhea or opportunistic infection.
The decision to explore the application of acalabrutinib in this patient population was based on known COVID-19 biology, the product’s mechanism of action and safety profile, and published preclinical data examining acalabrutinib in a mouse model for influenza, the researchers said in their announcement late Friday.
Calquence has been approved to treat adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It has also been approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Researchers from The U.S. Oncology Network were involved in the exploratory research due to their experience in the clinical development of acalabrutinib in B-cell chronic lymphocytic leukemia.
Jeff Shaman, medical director of Hematology Research for The U.S. Oncology Network and a co-author of the research, pointed to the overactive immune response some severely-ill COVID-19 patients have experienced.
“As lead investigator in the clinical trial which led to the approval of acalabrutinib for people with chronic lymphocytic leukemia, I have seen the drug’s ability to modify key immunologic signaling pathways shared by both cancer and the virus. I am encouraged by these initial results but further research is necessary to better understand the role of acalabrutinib in treating COVID-19,” Shaman said in a statement.
M. Andrew Monticelli, co-author of the manuscript and medical oncologist and hematologist at Rocky Mountain Cancer Centers, said the research team chose to conduct the project based on “very good science and the early experience from the NIH.” While the results generated from the small number of patients treated with Calquence is promising, Monticelli said it is essential that additional data be gathered through a randomized, clinical trial.
Based on the findings from this exploratory research project, AstraZeneca has initiated additional clinical studies evaluating acalabrutinib in seriously ill patients with over-reactive immune responses (cytokine storm) attributed to COVID-19 infection. These studies will examine acalabrutinib in two phase II trials in which acalabrutinib is compared to best supportive care in patients hospitalized with COVID-19, regardless of whether they are in an intensive care unit.
