Nearly 1/3 of Durable Responders Had No Evidence of Disease for ≥ 6 Months1

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

Primary endpoint2,4

The major efficacy outcome in the trial was durable response rate (DRR).

~1 in 6 patients had a complete response or partial response for ≥ 6 months.2

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

DRR, Defined

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

Chart demonstrating Durable Response Rate (DRR) with IMLYGIC

Chart demonstrating Durable Response Rate (DRR) with IMLYGIC

Secondary endpoint2

Time to response was a key secondary endpoint.

The median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC® arm.2

There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.2 The median OS in the overall study population was 22.9 months in the IMLYGIC® arm and 19.0 months in the GM-CSF arm (P = 0.116).2

REFERENCES

  1. Data on file, Amgen.
  2. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
  3. Kaufman HL, Bines SD. OPTiM trial: a Phase III trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage III or IV melanoma. Future Oncol. 2010;6:941-949.
  4. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33:2780-2788.
  5. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33(suppl Clinical Study Protocol):doi:10.1200/JCO.2014.58.3377.