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.1See how IMLYGIC® is different
- 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
IMLYGIC® has a proven safety profile1,5
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.1Read about dosing and administration
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
- IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
- 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.
- Data on file, Amgen; ; 2015.
- 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.
- 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.
- 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.
- 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.
- Data on file, Amgen; ; 2015.