Talimogene laherparepvec: Updated Phase III data

Updated data from an open-label, international Phase III trial in 436 patients with unresectable stage IIIB, IIIC or IV melanoma showed that talimogene laherparepvec missed the secondary endpoint of improving OS vs. GM-CSF (p=0.051). Amgen said the estimated OS hazard ratio and improvement in median OS were similar to that reported in a pre-defined interim analysis last year (23.3 vs. 19 months, HR=0.79, p=0.0746) (see BioCentury, Dec. 16, 2013). Patients received talimogene laherparepvec intralesionally every 2 weeks or GM-CSF subcutaneously for the first 14 days of each 28-day cycle. Treatment could last for up to 18 months. Amgen previously reported that talimogene laherparepvec met the primary endpoint of improving DRR (16% vs. 2%, p<0.0001) and the secondary endpoint of improving duration of response (HR=0.3, p=0.003) vs. GM-CSF (see BioCentury, March 25, 2013; June 10, 2013; & Oct. 14, 2013). Amgen gained the product through its 2011 acquisition of BioVex Inc. (see BioCentury, March 14, 2011). ...