Treatment with IMLYGIC® in earlier stages provided the most pronounced results1

OncovexGM-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.1-3

Primary endpoint1,2

The primary efficacy endpoint in the OPTiM pivotal trial was Durable Response Rate (DRR).

Nearly 1/3 of durable responders had no evidence of disease for ≥ 6 months4

Durable Response Rate1,2,4,5

Note: patients were staged based on the AJCC 7th edition.

CR: Disappearance of all evidence of tumor.5

PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors, as compared to baseline.5

Durable Response Rate – substage data1,4

Note: patients were staged based on the AJCC 7th edition.

CR: Disappearance of all evidence of tumor.5

PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors, as compared to baseline.5

Note: Among the PR → CR group, CR was not maintained for 6 continuous months.6

One patient disease substage was unknown.1

GM-CSF: CR of IIIB/C 0% (0/0), PR of IIIB/C 0% (0/0).4

§GM-CSF: CR of IVM1a 0% (0/1), PR of IVM1a 100% (1/1).4

**GM-CSF: CR of IVM1b/c 0% (0/2), PR of IVM1b/c 100% (2/2)4

CI = confidence interval; CR = Complete Response; DRR = Durable Response Rate; GM-CSF = granulocyte-macrophage colony-stimulating factor; PR = Partial Response.

DRR, Defined

The percent of patients with Complete Response or Partial Response maintained continuously for a minimum of 6 months.1,2

Key secondary endpoints1,2

The key secondary endpoints in the OPTiM pivotal trial were time to response, Overall Survival (OS) and Overall Response Rate (ORR).

  • The median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC® arm2
  • There was no statistically significant difference in OS between the IMLYGIC® and the GM-CSF arms. 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

Overall Response Rate1,5

*GM-CSF: CR of ORR 12.5% (1/8), PR of ORR 87.5% (7/8).1

Note: Patients were staged based on the AJCC 7th edition.

CR: Disappearance of all evidence of tumor.5

PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors, as compared to baseline.5

1 in 4 IMLYGIC® patients demonstrated a ≥ 50% reduction in tumor volume1,5

Overall Response Rate - substage data1,6

*GM-CSF: CR of ORR 12.5% (1/8), PR of ORR 87.5% (7/8).1

Note: Patients were staged based on the AJCC 7th edition.

CR: Disappearance of all evidence of tumor.5

PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors, as compared to baseline.5

1 in 4 IMLYGIC® patients demonstrated a ≥ 50% reduction in tumor volume1,5

Important ORR considerations:

CR and PR are the components of our prespecified objective of DRR, which is defined as the percentage of patients experiencing CR or PR lasting ≥ 6 months. However, the rates of CR and/or PR were not independent, prespecified endpoints. ORR, the percentage of patients experiencing CR or PR, was also not a prespecified objective; therefore, the study was not designed to statistically assess ORR.

One patient disease substage was unknown.1

GM-CSF: CR of IIIB/C 0% (0/1), PR of IIIB/C 100% (1/1).6

§GM-CSF: CR of IVM1a 0% (0/1), PR of IVM1a 100% (1/1).6

**GM-CSF: CR of IVM1b/c 16.7% (1/6), PR of IVM1b/c 83.3% (5/6)6


CR = Complete Response; DRR = Durable Response Rate; GM-CSF = granulocyte-macrophage colony-stimulating factor; ORR = Overall Response Rate; PR = Partial Response.

ORR, Defined

ORR was defined as the percentage of patients experiencing a CR or PR.1

REFERENCES

  1. 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.
  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. Data on file, Amgen; [1]; 2017.
  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.
  6. Data on file, Amgen; [2]; 2017.