Targeted failure of the week. Post No 44-45. Farletuzumab and Tredaptive

With mAb was everything according to expectations:

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) said IV farletuzumab plus carboplatin and taxane chemotherapy missed the primary endpoint of improving progression-free survival (PFS) vs. placebo plus carboplatin and taxane chemotherapy in the Phase III FAR 131 trial to treat platinum-sensitive epithelial ovarian cancer in first relapse. The double-blind, international trial enrolled 1,100 patients. Eisai, which said a post hoc exploratory analysis showed a trend toward improved PFS in undisclosed patient subgroups, said it will determine a new development strategy for farletuzumab based on discussion with external experts and health authorities.

With tredaptive the situation is also very sad:

Merck & Co is pulling its cholesterol drug Tredaptive, which has been available in Europe and elsewhere (although not the USA) in response to the negative findings of a recent late-stage trial.

 

Less than a month ago, the company presented data from the HPS2-THRIVE study of Tredaptive (extended-release niacin/laropiprant) which enrolled 25,673 patients considered to be at high risk for cardiovascular events. Data showed that adding the pill to statin therapy did not significantly further cut the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularisations.

There was also a statistically significant increase in the incidence of some non-fatal serious side effects in the Tredaptive group, Merck said at the time. Because of the data, the company has decided not to seek approval in the USA and is now withdrawing the drug from 40 countries.

The decision to suspend the medicine came as the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee also called for Tredaptive to be withdrawn after a review of the HPS2-THRIVE data.