EXAMPLEs of visible RESPONSES SEEN IN PATIENTS AFTER IMLYGIC® Injections

Examples of actual results with IMLYGIC®1

Individual results may vary.

Patient with a Partial Response
Photographs of a patient with a Partial Response
Before: Cycle 1
Photographs of a patient with a Partial Response
After: Cycle 10
Patient with a Complete Response
Photographs of a patient with a Complete Response
Before: Cycle 1
Photographs of a patient with a Complete Response
After: Cycle 4
Patient with a Partial Response
Photographs of a patient with a Partial Response
Before: Cycle 1
Photographs of a patient with a Partial Response
After: Cycle 15

OPTiM Pivotal Trial

  • Oncovex (GM-CSF) Pivotal Trial in Melanoma (OPTiM) was a phase 3, multicenter, open-label study of 436 stage IIIB, IIIC, and IV patients (previously treated and untreated). Patients had injectable, unresectable melanoma and were randomized 2:1 to receive IMLYGIC® or GM-CSF.2-4
  • The Durable Response Rate (DRR) was 16.3% in the IMLYGIC® arm (48/295) and 2.1% in the GM-CSF arm (3/141) in the overall study population. The unadjusted relative risk was 7.6 (95% CI: 2.4, 24.1); P < 0.0001. The median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC® arm.2,4
  • There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.2

REVIEW MORE INFORMATION ABOUT THE EFFICACY OF IMLYGIC®

See the data

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.