Roche ($RHHBY) has suffered a setback on one of a handful of top late-stage drugs in its pipeline. The pharma giant says that investigators at Genentech posted one win and one loss for identical Phase III studies for lebrikizumab, its targeted IL-13 contender for asthma.
The side-by-side studies were designed to give Roche a solid foundation of data for the approval and marketing of the anti-inflammatory drug for a clearly defined patient population. But while Lavolta I hit its primary endpoint on significantly cutting the rate of asthma exacerbations among patients selected on two key biomarkers for airway inflammation--levels of serum periostin or blood eosinophils--Lavolta II missed the exact same measure of efficacy.
Roche is holding back actual data now, but also noted that Lavolta I also hit its mark on lung function, a secondary endpoint measured by forced expiratory volume. More than 2,000 patients with severe asthma were recruited for the studies.
Mixed data for asthma won't help Roche garner the kind of revenue the pharma giant has been angling for. Asthma is a big, crowded field, and Roche has faced off against some major league rivals with a slate of Phase III efforts underway. AstraZeneca ($AZN) has been working on a late-stage program for benralizumab while the Regeneron/Sanofi crew have high hopes for dupilumab, an IL-4/IL-13 drug. And Teva is waiting on formal word from the FDA on its IL-5 asthma drug reslizumab after an FDA panel offered a unanimous recommendation for an OK back in December. The FDA panel, though, held back a recommendation for using Teva's drug for 12- to 17-year-olds, a key age group.
GlaxoSmithKline ($GSK) won an approval for mepolizumab last fall. It's an IL-5 injectable.
Dupilumab is widely expected to get to $1.8 billion in sales by 2020. But Roche faces some key hurdles, including shifting to a more personalized approach that requires identifying a specific patient population for asthma. Analysts at Credit Suisse pegged 2020 potential sales at $308 million. And now it has a targeted drug with mixed data to consider.
"We were hopeful these identical studies would confirm the Phase II results because there is still a significant unmet need for people with severe asthma," said Dr. Sandra Horning, chief medical officer and head of Global Product Development. "These data require further interpretation and analyses are ongoing to better understand the results and determine next steps."
Roche won't be backing away from asthma, though, regardless of what happens with lebrikizumab. The pharma giant just in-licensed an IL-33 drug--AMG 282--from Amgen ($AMGN) with plans to start a mid-stage program.
- here's the release