The Data Safety Monitoring Board completes its interim futility analysis of the PROCEED Phase 3 clinical trial of the Merck (MRK)/Endocyte (ECYT) cancer drug vintafolide. Since it did not demonstrate efficacy regarding its primary endpoint of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer, the Board recommends stopping the trial.
The trial was evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive platinum-resistant ovarian cancer. The primary endpoint was PFS as measured by RECIST v1.1 (Response Evaluation Criteria In Solid Tumor) criteria in patients with all target tumor lesions positive as assessed by the imaging agent etarfolatide.
The companies are in the process of notifying investigators that the trial will be suspended.
Trading in ECYT was halted at ~7:56 am EDT this morning pending the news.
Shares of MRK are down 0.2% premarket on light volume.