Vynfinit vintafolide: Additional Phase IIb data

Additional data from the open-label, international Phase IIb TARGET trial in 199 patients with stage IIIb or IV NSCLC showed that Vynfinit plus docetaxel non-significantly improved OS, a secondary endpoint, vs. docetaxel alone (HR=0.88, p=0.2874; HR=0.75 and p=0.1066 when adjusting for predefined patient characteristics). In a predefined subgroup of patients with folate-receptor positive adenocarcinoma recurrent NSCLC (n=92), Vynfinit plus docetaxel improved median PFS (4.2 vs. 3 months, HR=0.73, p=0.0899; HR=0.68 and p=0.0732 when adjusting for predefined patient characteristics), median OS (12.5 vs. 6.6 months, HR=0.7, p=0.1018; HR=0.51 and p=0.0147 when adjusting for predefined patient characteristics) and ORR (20.9% vs. 14.3%) vs. docetaxel alone. Data were presented at the European Society for Medical Oncology meeting in Madrid. Endocyte said it is evaluating its development plan for Vynfinit to determine whether to advance into Phase III testing once OS data from TARGET are mature.

In March, Endocyte said 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 (see BioCentury, March 24). 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). ...