NIH Reports Encouraging Results From Calquence Trial

Results from preliminary research show that AstraZeneca’s blood cancer treatment Calquence (acalabrutinib) provides a benefit in hospitalized COVID-19 patients.

The study led by the NIH’s National Cancer Institute looked at 19 severe COVID-19 patients. Over the course of treatment, Calquence improved oxygenation in a majority of patients. By the end of treatment, eight of 11 patients who had needed supplemental oxygen no longer needed it, and four of eight patients on mechanical ventilation were successfully extubated.

The company said the positive results support the initiation of global phase 2 trials, which were announced in March.

In the eight-patient invasive mechanical ventilation cohort, half of the patients were extubated following the treatment. Two were discharged from the hospital, one was on oxygen and weaning from it, and one died from an acute pulmonary embolism.

In its assessment of patients for disease recurrence, nine patients in the supplementary oxygen group were discharged on room air and remained well, one was still in the hospital, and one died. In the mechanical ventilation cohort, three patients were discharged and remained well, one was discharged to rehabilitation, and four patients died.

“In all, 12 patients achieved normal oxygenation on room air … and none have had a recurrence,” the researchers said, adding that they did not observe any treatment-related toxicities in the participants.

The promising results have led to the initiation of a pair of phase 2 studies of the drug. The studies will evaluate the addition of the drug to best supportive care in hospitalized patients who are not on assisted ventilation. One will be held in the U.S., while the other will be conducted in Europe, Japan and South America. — James Miessler