Oncovex (GM-CSF) Pivotal Trial in Melanoma (OPTiM) was a phase 3, multicenter, open-label study of 436 stage IIIB, IIIC, and IV patients. Patients had injectable, unresectable melanoma and were randomized 2:1 to receive IMLYGIC® or GM-CSF.2-4
The major efficacy outcome in the trial was durable response rate (DRR).
~1 in 6 patients had a CR and/or PR for ≥ 6 months.2,4
IMLYGIC® was injected into cutaneous, subcutaneous, or nodal melanoma lesions and was not injected into visceral lesions.2 Previous systemic treatment for melanoma was allowed.2
The percent of patients with complete response or partial response maintained continuously for a minimum of 6 months.*,2
*Complete response (CR): disappearance of all evidence of tumor.4,5 Partial response (PR): 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment, as compared to baseline.4,5 Tumor responses determined using modified WHO criteria by a blinded, independent Endpoint Assessment Committee (EAC).4,5