By Mark Terry


AstraZeneca released positive results from the BORA Phase III extension clinical trial of Fasenra (benralizumab) as an add-on maintenance therapy in patients with severe eosinophilic asthma that had already completed either the SIROCCO or CALIMA Phase III trials.

The BORA trial had patients receive Fasenra for another 56 weeks to evaluate long-term safety and efficacy. The drug showed a similar safety and tolerability profile as those seen in the placebo-controlled SIROCCO and CALIMA trials. In addition, the improvements seen in the patients’ illness were maintained over the additional year.

Patients who received placebo in the SIROCCO or CALIMA trials and subsequently received Fasenra also had improvements in their conditions.

“The BORA data are important news for patients with severe eosinophilic asthma who need a treatment with sustained efficacy to help control their disease, and with a safety profile that supports long-term use,” stated Sean Bohen, AstraZeneca’s executive vice president, Global Medicines Development and chief medical officer.

The overall rate of annual asthma exacerbation dropped on the drug, and overall improvements in lung function, asthma control, asthma-related and general health-related quality of life scores were maintained by those in the trial. Almost complete eosinophil depletion was seen in patients who continuously received Fasenra.

Worldwide, asthma affects about 339 million people. About 10 percent have severe asthma, which can require the use of chronic oral corticosteroids, which can have short-term and long-term side effects, such as weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression.

Fasenra is a monoclonal antibody that binds directly to the IL-5alpha receptor on eosinophils. This attracts natural killer cells, which depleted eosinophils by way of programmed cell death. Elevated levels of eosinophils, a type of white blood cell, are observed in about half of all severe asthma patients.

AstraZeneca is having a good week. On September 14, the U.S. Food and Drug Administration (FDA) approved Lumoxiti (moxetumomab pasudotox-tdfk) to treat adults with relapsed or refractory hairy cell leukemia (HCL) who received at least two previous systemic therapies.

The drug was approved under FDA Priority Review based on data from the Phase III “1053” trial.

“While many patients with hairy cell leukemia experience a remission with current treatments, 30 percent to 40 percent will relapse five to ten years after their first treatment,” stated Robert J. Kreitman, senior investigator, Head of Clinical Immunotherapy Section, Laboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute (NCI), and principal investigator of the Phase III clinical trial. “With subsequent treatments, durations of response diminish and toxicities accumulate, and few approved treatment options exist. Moxetumomab pasudotox represents a promising non-chemotherapeutic agent for HCL, addressing an unmet medical need for physicians and their patients.”

Hairy cell leukemia is a rare type of cancer. Patients typically respond well to existing therapies like chemotherapy, but 30 to 40 percent relapse after five to 10 years due to the cancer developing resistance to chemotherapy. The cancer is a slow-growing disease where the bone marrow produces too high levels of abnormal B-cell lymphocytes.

The Telegraph reported, “It’ll be seen as another coup for AstraZeneca’s chief executive, Pascal Soriot. His strategy since he took over in 2012 has been to pump huge amounts of money into four key areas of research, one of which is oncology, in the hope of finding breakthrough treatments that will generate money for the company and offset declining revenues from older drugs that have gone off patent.”



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