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Roche Discontinues Dalcetrapib Development

Trial shows lack of clinically meaningful efficacy

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Roche has discontinued development of Dalcetrapib, an HDL-raising CETP inhibitor being studied in coronary heart disease, following the results of the second interim analysis of the dalcetrapib dal-OUTCOMES Phase III trial. An independent Data and Safety Monitoring Board (DSMB) recommended stopping the trial due to a lack of clinically meaningful efficacy.

“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 M.D., 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 NMEs in late-stage development.

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