- One of two identical phase 3 studies of Roche’s asthma drug lebrikuzumab failed to meet its primary endpoint, in a disappointment for the Swiss drugmaker.
- The second study did demonstrate improvement in measured lung function, but the mixed results will require further analysis to move the drug forward. Lebrikizumab is an injectable antibody drug that blocks interleukin-13.
- Separately, the FDA on Monday approved Roche’s lymphoma drug Gazyva for second-line treatment of follicular lymphoma.
First the bad news. Roche was unable to replicate its positive results from a phase 2 study in which lebrikuzumab significantly reduced the number of exacerbations in patients with severe asthma.
Roche/Novartis’ Xolair was once the sole monoclonal antibody treatment option for asthma, but new entrants are rapidly changing the market. GlaxoSmithKline’s (GSK) recently introduced its injectable IL-5 monoclonal antibody Nucala, which treats severe asthma in patients who are non-responsive to high-dose inhaled corticosteroids.
Roche’s fortunes received a boost, however, with FDA second-line approval for Gazyva, which was approved on the back of strong phase 3 data. Patients with advanced follicular lymphoma who received a combo treatment including Gazyva experienced a comparative 52% improvement in progression-free survival.
While Gazyva is a new type of immunologic drug, lebrikuzumab faces stiff competition in a growing field of asthma treatments. Roche plans to re-analyze the conflicting Phase 3 data in order to decide on a way forward.