Vynfinit vintafolide: Phase IIb data

The open-label, international Phase IIb TARGET trial in 199 patients with stage IIIb or IV NSCLC showed that Vynfinit plus docetaxel met the primary endpoint of improving PFS vs. docetaxel alone (HR=0.75; p=0.0696). Endocyte said the predefined threshold for meeting the endpoint was a p-value of <0.1. The trial is comparing 2.5 mg Vynfinit given on days 1, 4, 8 and 11 as a single agent and in combination with docetaxel vs. docetaxel alone. Last year, an independent DSMB said the Vynfinit monotherapy arm in TARGET was "unlikely" to be superior to docetaxel on the primary endpoint of PFS based on an interim futility analysis (see BioCentury, Oct. 14, 2013).

Endocyte also said data for secondary endpoints, including ORR and OS, showed trends in favor of the combination arm. Median OS has been reached for the Vynfinit and docetaxel monotherapy arms, but has not yet been reached in the combination arm. Additionally, Vynfinit plus docetaxel showed "better activity" in a pre-specified subgroup of patients with adenocarcinoma, but details were not disclosed. The trial enrolled patients who have failed >=1 prior chemotherapy whose target lesions all express the folate receptor as determined by Endocyte's companion imaging diagnostic Folcepri etarfolatide, a folate-targeted radiopharmaceutical imaging agent. The company expects OS data from TARGET to mature later this year. ...