Study of GSK’s Volibris, Lilly’s Adcirca Shows Reduced Clinical Failure Events
Patients who got a combination of GlaxoSmithKline’s Volibris and Eli Lilly’s Adcirca to treat pulmonary arterial hypertension had significantly less hospitalization, disease progression or death compared with those getting monotherapy in a Phase 3b/4 study, newly released data show.
The 500-patient AMBITION study showed clinical failure events in just 18 percent of those receiving the combo versus 34 percent of patients on Volibris (ambrisentan) alone and 28 percent of those getting Adcirca (tadalafil).
Patients receiving the combo also had greater improvement in the six-minute walk distance, adding 49 meters compared with 24 meters in the monotherapy group. The results were published in the New England Journal of Medicine last week.
Murray Stewart, chief medical officer at GSK, said that while combination therapy is commonly used to treat patients with pulmonary arterial hypertension, clinical trials on combo regimens have been limited to sequential add-on therapy, resulting in a lack of evidence about when and how combination treatment could and should be used.
GSK says regulatory submissions to include the trial data in Volibris’ labeling are planned for the U.S., EU and other countries. Lilly could not be reached for comment by press time. — Jonathon Shacat