AstraZeneca’s Calquence Shows Improvement in Two Clinical Trials

AstraZeneca recently announced that its drug, Calquence (acalabrutinib), showed long-term efficacy and tolerability for patients with chronic lymphocytic leukemia (CLL) in two clinical trials. 

The news comes on the heels of a recent study that found the blood cancer drug benefitted a small group of patients hospitalized with severe COVID-19.

The latest clinical dosed patients with 200mg of acalabrutinib once daily and found an overall response rate of 97 percent. In patients with high-risk disease characteristics, researchers saw a 100 percent overall response rate.

Eighty-six percent of patients receiving acalabrutinib in 1st-line monotherapy stayed on treatment for more than four years following the trial.

The second trial, Phase III ASCEND, dosed relapsed or refractory CLL patients twice daily with 100 mg of acalabrutinib. The trial found that 82 percent of patients remained alive and saw no disease progression at 18 months, compared to patients receiving rituximab combined with idelalisib or bendamustine, AstraZeneca said.

There were no safety issued identified in either study. 

“These data demonstrate no new safety concerns for acalabrutinib, confirming its ability to safely provide meaningful, long-term clinical benefit for patients with treatment-naive and relapsed or refractory disease. The safety profile of acalabrutinib makes treatment to progression an important and plausible option for patients,” Richard R. Furman, director of the CLL research center, Weill Cornell Medicine, said in the announcement. 

Acalabrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor originally used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment. 

But CLL is one of the most common types of leukemia in adults and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease. AstraZeneca estimated 21,040 new cases will occur in the US in 2020. 

The results from the Phase II ACE-CL-001 trial will advance the development of the pivotal Phase III ELEVATE TN trial.

Both ACE-CL-001 and the ASCEND trial formed the basis for the US approval of acalabrutinib, for the treatment of patients with CLL or small lymphocytic lymphoma (SLL). 

“These long-term data reaffirm that Calquence delivers a durable response with a favourable safety profile for chronic lymphocytic leukaemia patients,” said Jose Baselga, executive vice president, oncology R&D. 

“Patients with chronic lymphocytic leukaemia are typically 70 years or older with comorbidities and often require treatment over a long time, making the sustained safety and efficacy profile highly relevant to their quality of life.”

But the drug has also proven to help patients with the novel coronavirus. 

Last week, AstraZeneca announced that acalabrutinib reduced inflammation and improved clinical outcomes in patients with severe COVID-19.

The National Institutes of Health (NIH) and AstraZeneca scientists led the peer-reviewed case series of 19 hospitalized COVID-19 patients with severe hypoxia and inflammation. The results were recently published in Science Immunology.

Researchers administered the drug in patients with severe respiratory illness caused but SARS-CoV-2 because evidence suggested that dysregulated BTK-dependent lung macrophage signaling mediates cytokine storm and could play a role in COVID-19 pneumonia.

“The science supporting investigation of the use of Calquence in patients with severe COVID-19 is strong,” said Jose Baselga. 

“The encouraging preliminary data in this case series has informed the initiation of global phase II trials, notably the CALAVI programme. We look forward to completing recruitment and obtaining data in these trials as soon as possible to further our understanding of what this potential treatment could mean for patients.”