Phase III LYNK 003 trial of Lynparza for colorectal cancer is stopped for futility

This action follows the recommendation of an independent Data Monitoring Committee (DMC), after the DMC reviewed the data from a planned interim analysis. Lynparza is a PARP inhibitor that is being co-developed and co-commercialized with AstraZeneca.

At the pre-specified interim analysis for progression-free survival, the efficacy of Lynparza as a monotherapy and in combination with bevacizumab relative to control met the criteria for futility by the DMC and accordingly, both experimental arms will be discontinued. No new safety signals were observed with Lynparza in this trial, and the safety profiles of both Lynparza monotherapy and Lynparza combined with bevacizumab in this trial were generally consistent with that observed in previously reported studies. Merck will inform study investigators of the recommendation from the DMC and will advise patients in the trial to speak to their physician regarding treatment options. Data from this study will be shared in a future scientific forum.

LYNK-003 is one of several trials initiated by Merck as part of the extensive Lynparza clinical development program. In addition to colorectal cancer, Lynparza is also being studied by Merck, in collaboration with AstraZeneca, as both monotherapy and in new combinations across a range of DNA damage response deficient tumor types, including metastatic prostate cancer, ovarian cancer, breast cancer and pancreatic cancer.