Gil Roth10.15.13
Merck and Endocyte have published results from the Phase II trial for vintafolide, an investigational folate small molecule drug conjugate (SMDC). Those results form the basis for the vintafolide regulatory application currently under review with the EMA for the treatment of folate-receptor positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin (PLD). Enrollment is ongoing in the treatment's Phase III trial, which is being conducted along with investigational companion imaging agent etarfolatide (EC20), in platinum-resistant ovarian cancer.
The Phase II trial showed that administration of vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD alone in women with platinum-resistant ovarian cancer resulted in a median progression-free survival (PFS) of 5.0 months compared to 2.7 months for those treated with PLD alone in the intent-to-treat (ITT) population. Patients shown to have folate receptor-positive tumors, as defined by all selected target lesions being folate receptor-positive using the investigational folate receptor-targeted companion diagnostic imaging agent etarfolatide, demonstrated greater benefit, as measured by PFS, from treatment with vintafolide plus PLD versus PLD alone. Median PFS benefit in these patients was 5.5 months compared to 1.5 months for PLD alone. Etarfolatide is being developed by Endocyte as a non-invasive method to identify tumors that express the folate receptor.
The Phase II trial was an international, multi-center, randomized study of 149 women with platinum-resistant ovarian cancer. The combination of vintafolide and PLD was generally well tolerated, and no drug-related mortality or statistically significant difference in the incidence of drug-related serious treatment-emergent adverse events (TEAEs) was observed.
The Phase II trial showed that administration of vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD alone in women with platinum-resistant ovarian cancer resulted in a median progression-free survival (PFS) of 5.0 months compared to 2.7 months for those treated with PLD alone in the intent-to-treat (ITT) population. Patients shown to have folate receptor-positive tumors, as defined by all selected target lesions being folate receptor-positive using the investigational folate receptor-targeted companion diagnostic imaging agent etarfolatide, demonstrated greater benefit, as measured by PFS, from treatment with vintafolide plus PLD versus PLD alone. Median PFS benefit in these patients was 5.5 months compared to 1.5 months for PLD alone. Etarfolatide is being developed by Endocyte as a non-invasive method to identify tumors that express the folate receptor.
The Phase II trial was an international, multi-center, randomized study of 149 women with platinum-resistant ovarian cancer. The combination of vintafolide and PLD was generally well tolerated, and no drug-related mortality or statistically significant difference in the incidence of drug-related serious treatment-emergent adverse events (TEAEs) was observed.