AstraZeneca and its biologics research-and-development arm, MedImmune, indicated that its Fasenra (benralizumab) did not meet its primary endpoint in patients with moderate to very severe COPD.
AstraZeneca and its biologics research-and-development arm, MedImmune, indicated that its Fasenra (benralizumab) did not meet its primary endpoint in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
This was the result of the company’s GALATHEA Phase III clinical trial. The primary clinical endpoint was a statistically-significant decrease of exacerbations in COPD patients.
The GALATHEA and TERRANOVA trials are randomized, double-blinded, 56-week placebo-controlled, multi-center trials assessing Fasenra as an add-on to dual or triple inhaled therapy compared to placebo.
Fasenra is a monoclonal antibody that stimulates natural killer cells to cause rapid and near-complete depletion of eosinophils, a type of white blood cell. The drug has been approved in severe eosinophilic asthma in the U.S., Europe, Japan, Canada and Australia, and is being reviewed in several other countries and regions.
“COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies,” said Sean Bohen, AstraZeneca’s executive vice president, Global Medicines Developoment and chief medical officer, in a statement. “We will now await the results of Terranova and a full evaluation of both trials to determine next steps for Fasenra in COPD.”
The GALATHEA trial evaluated about 2,000 patients. The TERRANOVA trial is about the same size. Results from the TERRANOVA trial are expected sometime this quarter.
Although disappointing for COPD, Matthew Kent, an AstraZeneca spokesman, indicated that its launch in asthma is exceeding expectations.
Late last month, AllianceRx Walgreens Prime, the central specialty and home delivery pharmacy formed by Walgreens and pharmacy benefit manager Prime Therapeutics, along with Walgreens, announced that Fasenra was one of four drugs now available to their patients to treat rare conditions.
“Continually expanding on our industry-leading limited distribution drug list demonstrates our passion and commitment to making sure patients have access to the medications they need, including those that may be hard to find,” said Joel Wright, chief executive officer of AllianceRx Walgreens Prime, in a statement. “We are pleased to offer these medications as additional options to help treat patients who have been diagnosed with these serious conditions, and continue to work with Walgreens at the community-based specialty pharmacies as well.”
Fasenra was added for add-on maintenance therapy for patients with severe asthma aged 12 years and older. Additional drugs include Teva Pharmaceuticals’ Austedo for Hungtingon’s disease; Genentech’s Hemlibra for the prevention of bleeds associated with hemophilia A (congenital factor VIII deficiency); and Vertex Pharmaceuticals’ Symdeko for cystic fibrosis (CF) in patients 12 years and older who have two copies of the F508del mutation or one mutation that is response to the drug. Symdeko is also available at select Walgreens community-based specialty pharmacies.
It was only about three weeks ago that AstraZeneca announced data from its Phase III ARCTIC clinical trial of Imfinzi (durvalumab) plus tremelimumab in locally-advanced or metastatic non-small cell lung cnacer (NSCLC) in patients who received at least two previous treatments, failed to meet the trial’s primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to standard of care.
