Merck And Endocyte Announce CHMP Positive Opinions For Vynfinit - Quick Facts

(RTTNews) - Merck (MRK), known as MSD outside the United States and Canada, and Endocyte Inc. (ECYT), announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has issued positive opinions for the Conditional Marketing Authorisations of Vynfinit or vintafolide and companion imaging components, imaging agent Folcepri or etarfolatide, and Neocepri (intravenous (IV) folic acid), for the treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin or PLD.

Vintafolide is proposed for use in combination with PLD for the treatment of adult patients with platinum-resistant ovarian cancer who express the folate receptor on all target lesions. Folate receptor status should be assessed by a diagnostic medicinal product approved for the selection of adult patients for treatment with vintafolide, using Single Photon Emission Computed Tomography (SPECT) imaging, in combination with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).

Etarfolatide and IV folic acid are medicinal products proposed for diagnostic use only. Etarfolatide, following radiolabelling with sodium pertechnetate (99mTc) solution, is proposed for SPECT imaging in combination with CT or MRI, for the selection of adult patients for treatment with vintafolide. Intravenous folic acid would be administrated prior to 99mTc-etarfolatide for the enhancement of SPECT image quality.

In a separate press release, Endocyte announced results from the Phase 2b TARGET trial, which showed that the study met the primary endpoint for the combination of vintafolide (EC145/MK-8109) and docetaxel in folate receptor (FR)-positive recurrent non-small cell lung cancer or NSCLC patients.

The data showed that risk of disease worsening or death was reduced by 25 percent for patients treated with the vintafolide/docetaxel combination versus docetaxel alone (PFS HR 0.75, p-value 0.0696, one-sided test).

The TARGET Phase 2b trial was conducted in 199 patients, randomized to one of three arms: vintafolide alone, vintafolide/docetaxel combination, or docetaxel alone. Secondary endpoints, including overall response rate and overall survival or OS, also showed trends in favor of the combination arm. Median OS has been reached for the vintafolide and docetaxel single-agent arms but has not yet been reached in the combination arm. In addition, the investigational combination regimen showed better activity in patients with adenocarcinoma, a subset analysis pre-specified in the trial design.

According to Endocyte, the safety profile of the combination arm was consistent with those observed with docetaxel alone and vintafolide alone, though a higher rate of hematologic and peripheral neuropathy adverse events were observed in the combination arm. There were no drug-related deaths in the combination arm. Single-agent vintafolide at the schedule evaluated in this study demonstrated less activity than single-agent docetaxel.