GlaxoSmithKline has published full results from the phase III studies for mepolizumab in chronic obstructive pulmonary disease (COPD). For people living with COPD, a sudden worsening of their symptoms, known as an exacerbation, causes them to struggle to breathe despite receiving the available guideline recommended treatment. For these patients, there are currently no other treatment options.
Data from the investigational clinical development programme showed that treating eosinophilic COPD patients with the biologic medicine, mepolizumab, in addition to maximal guideline-recommended therapy, reduced exacerbations in these difficult-to-treat patients.
GSK says it plans to progress regulatory filing in 2017. Mepolizumab is not approved for use anywhere in the world for COPD.
Results have been published in the New England Journal of Medicine (NEJM), with simultaneous presentation at the European Respiratory Society (ERS) International Congress 2017.
The studies tested mepolizumab as add-on therapy in the reduction of COPD exacerbations in patients at high risk of exacerbations. They also identified the patients with COPD most likely to respond to treatment using blood eosinophils, which can play a role in some inflammatory diseases, as a biomarker.
Overall, COPD patients treated showed a consistent 18-20% reduction in the primary endpoint of annual rate of moderate and severe exacerbations.
In METREO, the reduction was not statistically significant at 20%, p=0.068 after multiplicity adjustment.
There was no evidence of greater treatment effect in patients treated with a higher (300mg) dose of mepolizumab investigated in the dose ranging METREO study. In the METREX study, patients with blood eosinophil counts of less than 150 cells/µL at the start of the study were not found to benefit from mepolizumab.
For the secondary endpoints, there was a statistically significant increase in the time to first moderate and severe exacerbation in METREX, with numerical, but not significant, increase in time to first exacerbation in METREO. There were no significant differences between mepolizumab and placebo in either study on the remaining secondary endpoints: annual rate of exacerbations requiring emergency department visit and/or hospitalisation, St George’s Respiratory Questionnaire score and COPD assessment test score.
Steve Yancey, Vice President and Medicine Development Lead for mepolizumab, GSK said that the data demonstrate the benefits of a personalised medicine approach in the treatment of COPD with mepolizumab, using blood eosinophils as a biomarker.
Professor Ian Pavord, University of Oxford said: “When considering the challenges these patients face, the exacerbation reduction shown in the METREX and METREO studies is a clinically important outcome.”
Image: The GlaxoSmithKline building is pictured in Hounslow, west London