As the world awaits a COVID-19 vaccine, medical researchers are racing to find the next best thing: treatments that can improve the outcome and potentially save the lives of patients infected with the deadly virus. In a groundbreaking new manuscript, published in The study in Science Immunology: Inhibition of Bruton tyrosine kinase in patients with severe COVID-19, physician researchers within The US Oncology Network have helped to uncover one such promising treatment – the cancer drug acalabrutinib, commercially available as Calquence from AstraZeneca.
In the manuscript – co-authored by Jeff Sharman, MD, medical director of Hematology Research for The US Oncology Network and oncologist/hematologist with Willamette Valley Cancer Institute and Research Center, and M. Andrew Monticelli, MD, medical oncologist and hematologist at Rocky Mountain Cancer Centers – results show that the off-label use of acalabrutinib led to rapid improvements in a small group of advanced COVID-19 patients. Conducted in collaboration with the National Institutes of Health (NIH) and AstraZeneca, the exploratory research examined the effects of acalabrutinib in 19 patients with acute respiratory distress syndrome (ARDS) caused by the coronavirus.
The results offer a ray of hope in the fight against COVID-19. After receiving treatment with acalabrutinib, eight out of 11 patients on oxygen therapy no longer needed oxygen therapy at the time of the research report, and seven were discharged from the hospital. In addition, four out of eight patients who were on a ventilator prior to receiving acalabrutinib were taken off the ventilator, and two were discharged from the hospital at the time of the report.
How Can a Blood Cancer Drug Help Treat Patients with COVID-19?
The answer lies in the mechanism of acalabrutinib, which is designed to calm the body’s overly aggressive immune response (or “cytokine storm”) to an invader or infection, whether it’s a blood cancer or the novel coronavirus. Acalabrutinib is a member of a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors, which may calm the immune response and give the lungs a chance to recover.
“When COVID-19 infects the respiratory pathway, the body creates a hyperactive immune response to the virus. This excessive inflammation causes significant damage to the lungs and the patient’s ability to breath,” explained Dr. Sharman, who served as a lead investigator in the clinical trial which led to the FDA approval of acalabrutinib for people with a form of blood cancer. “I have seen this drug’s ability to improve outcomes in cancers of the immune system, and I’m encouraged by these initial results.”
Encouraged by the NIH to conduct this exploratory research, Dr. Sharman and other physician investigators treated patients at Rocky Mountain Cancer Centers in Colorado, New York Oncology Hematology in New York and Walter Reed Medical Center in Washington, D.C. Patients ranging in age from 45 to 84 received the drug under a compassionate use program authorized by AstraZeneca and the U.S. Food and Drug Administration (FDA).
“We are fortunate to be able to draw on our previous research and put the science to work in a new way, and it’s very gratifying to see patients respond well, get off ventilators and leave the hospital,” said Dr. Monticelli. “But our work doesn’t end here. It’s essential that we conduct a randomized, controlled trial to collect more evidence and advance the science so the medical world can use it to our best advantage.”
A Leader in Life-Saving Research
Usually available only in major academic medical centers or hospital systems located in large cities, the clinical trials conducted by US Oncology Research – the research arm of The US Oncology Network – bring world-class science to patients right in their local communities. So far, practices in The Network have offered more than 1,600 clinical trials to patients and played a role in over 95 FDA-approved oncology therapies.
“At this extraordinary moment, all eyes are turning to medical research to help lead us through the COVID-19 health crisis,” said Michael Seiden, MD, president of The Network. “In addition to offering much-needed hope, this study helps to spotlight the vital work of US Oncology Research, which has always been a source of great pride to our physician community and a tremendous asset to patients.”