Primary overall survival (OS) from OPTiM, a randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma.

9008a Background: T-VEC is an oncolytic immunotherapy derived from herpes simplex virus type-1 designed to selectively replicate in tumors and produce GM-CSF to enhance systemic antitumor immune responses. OPTiM is a randomized, phase 3 trial of T-VEC or GM-CSF in patients (pts) with unresected melanoma with regional or distant metastases (NCT00769704). OPTiM met the primary endpoint of a statistically significant improvement in durable response rate (DRR) with T-VEC vs GM-CSF (Andtbacka et al. ASCO 2013). The primary analysis of OS is reported here. Methods: Key entry criteria were age ≥ 18 yrs, ECOG ≤1, unresectable melanoma stage IIIB/C or IV, injectable cutaneous, SC, or nodal lesions, LDH ≤1.5X ULN, ≤ 3 visceral lesions (excluding lung), none > 3 cm. Pts were randomized 2:1 to intralesional T-VEC (initially ≤ 4 mL x106 pfu/mL then after 3 wks, ≤ 4 mL x108 pfu/mL Q2W) or SC GM-CSF (125 µg/m2qd x 14 days q28d). The primary endpoint was DRR: partial or complete response continuously for ≥ 6 mos starting...