February 29, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Genentech , a division of Switzerland-based Roche Holding AG (RHHBY), announced the results of two Phase III studies of lebrikizumab in patients with severe asthma. One study met its primary endpoint, but not as well as seen in Phase II clinical trials. And in the second trial, the drug did not meet its primary endpoints.
The first trial, LAVOLTA I, showed a significant decrease in the rate of asthma exacerbations in patients with higher levels of serum periostin or blood eosinophils, which are both biomarkers for airway inflammation. LAVOLTA I also showed significant improvement in lung function as measured by forced expiratory volume in one second (FEV1).
Unfortunately, the primary and secondary endpoints observed were less than seen in lebrikizumab Phase II trials.
The LAVOLTA II trial did not meet either of the endpoints with statistical significance.
“We were hopeful these identical studies would confirm the Phase II results because there is still a significant unmet need for people with severe asthma,” said Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, in a statement. “These data require further interpretation and analyses are ongoing to better understand the results and determine next steps.”
Lebrikizumab is a humanized monoclonal antibody designed to block the action of interleukin-13 (IL-13). IL-13 plays a significant role in airway inflammation and asthma. The drug is also being studied in asthma, chronic obstructive pulmonary disease (COPD), atopic dermatitis (AD) and idiopathic pulmonary fibrosis (IPF).
On a more positive note, Genentech announced that it had been granted approval by the FDA for Gazyvaro to treat some patients with previously treated follicular lymphoma, the most common type of indolent non-Hodgkin’s lymphoma. The FDA approved the use of the drug alongside bendamustine chemotherapy followed by Gazyva (obinutuzumab) alone. Gazyvar is a type II anti-CD20 monoclonal antibody that works more aggressively than type I treatments like Rituxan.
Gazyvar is already being marketed in the U.S. for patients with previously untreated chronic lymphocytic leukemia (CLL).
Although the new studies for asthma were disappointing, and competition is fierce in the asthma market, the company recently in-licensed AMG-282, an IL-33 drug, from Amgen . Amgen’s upfront payment from Roche was undisclosed. It is eligible for milestone and royalty payments. Genentech plans to conduct a Phase II trial of the drug in asthma and COPD, but no timeline has been revealed.
GlaxoSmithKline ’s Nucala for asthma was recently approved by the FDA and the European Medicines Agency for maintenance treatment of severe asthma in patients 12 years and older. The drug is an IL-5 inhibitor, and is a biologic.
AstraZeneca has benralizumab for asthma. The company signed an option deal with Kyowa Hakko Kirin Co., Ltd. for the drug for asthma and COPD in Japan last year. AstraZeneca paid Kyowa Hakko Kirin $45 million upfront, with various milestone and royalty payments possible. It is being evaluated in the U.S. with regulatory filings expected this year.
Teva is waiting on its own IL-5 asthma drug, reslizumab. An FDA panel gave it a unanimous recommendation in December 2015. A decision is expected in March 2016.
