In unresectable melanoma recurrent after initial surgery

Inject the lesion. Trigger an immune response. That's the precision of IMLYGIC®1,*

*IMLYGIC® is the first and only FDA-approved2 oncolytic viral therapy designed to replicate in cancer cells, leading to oncolysis, whereby the release of tumor-derived antigens, virally derived GM-CSF, and replicated IMLYGIC® may promote an antitumor immune response.1 The exact mechanism of action is unknown.1

See how IMLYGIC® is different

In OPTiM, IMLYGIC® delivered a Durable Response—

shown continuously for 6 months or more1,3

~1 IN 6 PATIENTS HAD A CR AND/OR PR FOR ≥ 6 MONTHS1,5

See 3 examples of actual results
  • 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.1,4,5
  • 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.1,5
  • There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.1

DRR: defined as the percent of patients with a CR or PR maintained continuously for a minimum of 6 months1; Complete response (CR): disappearance of all evidence of tumor5,6; 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 baseline5,6; Tumor responses were determined using modified WHO criteria by a blinded, independent Endpoint Assessment Committee (EAC)5,6; GM-CSF = granulocyte-macrophage colony-stimulating factor.

*Ongoing response refers to the primary endpoint of Durable Response Rate, defined as the percent of patients with a Complete Response or Partial Response maintained continuously for a minimum of 6 months.

Patients with stage IIIB, IIIC, or IV melanoma that was not considered to be surgically resectable experienced ongoing* and clinically meaningful responses with IMLYGIC®.1,5,7

Patient with Complete Response8,†
Photographs of a patient with a Complete Response
Before: Cycle 1
Photographs of a patient with a Complete Response
After: Cycle 13
Patient with Partial Response8
Photographs of a patient with a Partial Response
Before: Cycle 1
Photographs of a patient with a Partial Response
After: Cycle 10

*Ongoing response refers to the primary endpoint of Durable Response Rate, defined as the percent of patients with a Complete Response or Partial Response maintained continuously for a minimum of 6 months.

†CR confirmed by biopsy.6
Individual results may vary.
Examples shown are for two patients in the phase 3 study.

Review the efficacy of IMLYGIC®

IMLYGIC® has a proven safety profile1,5

Evaluate the safety of IMLYGIC®

IMLYGIC® starts with injection directly into the lesion1

Administer IMLYGIC® by intralesional injection into cutaneous, subcutaneous, and nodal lesions that are visible, palpable, or detectable by ultrasound guidance; do not administer intravenously.1

Read about dosing and administration
Injection video

This injection video demonstrates an example of how to administer intralesional injections of IMLYGIC®. This video does not replace the Prescribing Information. Please review the Prescribing Information prior to administering IMLYGIC®.

This injection video demonstrates an example of how to administer intralesional injections of IMLYGIC®. This video does not replace the Prescribing Information. Please review the Prescribing Information prior to administering IMLYGIC®.

IMLYGIC® has special storage and handling considerations1

Information on storage requirements of IMLYGIC®, as well as details on procurement, ordering, and safe handling. This video does not replace the Prescribing Information. Please review the Prescribing Information prior to handling IMLYGIC®.

Learn more about IMLYGIC® storage and handling details
Storage and handling video

This step-by-step video describes what to do when you receive a shipment of IMLYGIC®, including instructions on storage and safe handling requirements.

This step-by-step video describes what to do when you receive a shipment of IMLYGIC®, including instructions on storage and safe handling requirements.

REFERENCES

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
  2. FDA News Release. FDA approves first-of-its-kind product for the treatment of melanoma. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm. Released October 27, 2015. Accessed March 24, 2017.
  3. Data on file, Amgen; [1]; 2015.
  4. 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.
  5. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33:2780-2788.
  6. 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.
  7. US Food and Drug Administration. Summary basis for regulatory action. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/Approved/Products/UCM473103.pdf. Published October 27, 2015. Accessed March 24, 2017.
  8. Data on file, Amgen; [2]; 2015.