The independent Data and Safety Monitoring Board (DSMB) has asked Roche to stop the second interim analysis of the dalcetrapib dal-OUTCOMES phase III trial due to a lack of clinically meaningful efficacy.
The dal-OUTCOMES trial evaluated the efficacy and safety profile of dalcetrapib when added to existing standard ofcare in patients with stable coronary heart disease (CHD) following an acute coronary syndrome (ACS). Nosafety signals relating to the dal-OUTCOMES trial were reported from the DSMB.
“Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn't provide benefit to the patients in our study,” said Hal Barron MD, Chief Medical Officer and Head, Global Product Development. “We continue to be fully committed to the development of innovative medicines for people with cardiovascular disease. Our pipeline remains robust with 23 positive late-stage clinical trials reporting over the past 16 months and a significant increase in New Molecular Entities in late-stage development.”
Roche has decided to terminate the dal-OUTCOMES trial and all the studies in the dal-HEART programme. Roche will update all stakeholders further in due course.
The dal-HEART is a global development programme involving six clinical trials: dal-OUTCOMES, dal-OUTCOMES 2, dal-PLAQUE 2, dal-ACUTE, dal-PLAQUE (completed) and dal-VESSEL (completed).