Merck And Endocyte Withdraw CMAs For Ovarian Cancer Drugs

Merck and its collaboration partner Endocyte announced that the companies are withdrawing conditional marketing authorization applications (CMAs) from the European Medicines Agency (EMA) for their ovarian cancer treatments.

These treatments are vintafolide and companion imaging components, imaging agent etarfolatide and intravenous (IV) folic acid, intended as treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD).

Endocyte and Merck’s decision was based on additional review of data from the PROCEED trial. The Data Safety Monitoring Board has earlier recommended that the study be terminated due to failure of vintafolide in combination with PLD versus PLD alone to demonstrate progression-free survival in patients according to pre-specified criteria. Enrollment in the study was suspended as a result, though the DSMB did not mention any safety concerns for the patients involved in the trial.

PROCEED is double-blind, randomized, Phase III clinical trial assessing vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant ovarian cancer. Merck and Endocyte the companies will take steps to end the Phase III trial and will provide study investigators instruction for its conclusion. The companies said it will present study results in a future scientific congress.

“Advanced stage ovarian cancer is a difficult-to-treat disease with few options available, and we are disappointed by the outcome of this confirmatory study. We would like to thank our clinical investigators and especially the patients with platinum-resistant ovarian cancer who participated in the clinical studies for these investigational candidates,” said the companies in a joint press release.

The randomized Phase IIB TARGET trial is still ongoing in patients with non-small cell lung cancer (NSCLC). Maturation of overall survival data is expected later this year to guide possible further development of vintafolide and docetaxel combination treatment in NSCLC.