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DSMB recommends stopping vintafolide trial

  • 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.
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Comments (2)
  • gtago4it
    , contributor
    Comments (3) | Send Message
     
    jbseget
    Platinum-resistant ovarian cancer is one tough baby to address. The sole criteria for taking on those for clinical evaluation appeared to be solely whether the patients exhibited the foliate receptor. However, was consideration given as to how many in the study had advanced ovarian cancer? I don't see how the drug could have been very helpful if metastasis had already occurred. Just my opinion
    19 May, 08:39 PM Reply Like
  • biochemist
    , contributor
    Comments (385) | Send Message
     
    Agree that PROC is very difficult to treat. All patients in the study had to have 100% of their lesions express the folate receptor. Patients were then treated with vintafolide and PLD, the standard of care. The data from the Phase 2 trial showed a benefit in PFS for the vintafolide + PLD patients vs. PLD alone. That apparently was not replicated in the Phase 3 trial.
    20 May, 05:19 PM Reply Like
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