Frequently Asked Questions

  • What results were seen in clinical trials of IMLYGIC®?

    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.1,2

    The primary endpoint in the trial was Durable Response Rate (DRR), defined as the percent of patients with a complete response (CR) or partial response (PR) maintained continuously for a minimum of 6 months.1,*

    The 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 < 0.0001.1

    There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.

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

    *Complete response (CR): disappearance of all evidence of tumor.3,4 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.3,4 Tumor responses determined using modified WHO criteria by a blinded, independent Endpoint Assessment Committee (EAC).3,4

    See more information about the durable response here.

  • What is the time to response with IMLYGIC®?

    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.1,2

    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. Time to response was a key secondary endpoint.1 The median time to response was 4.1 (range: 1.2 to 16.7) months in the IMLYGIC® arm.1,3

    There was no statistically significant difference in overall survival (OS) between the IMLYGIC® and the GM-CSF arms.1

    Continue treatment with IMLYGIC® for at least 6 months—unless other treatment is required or until there are no injectable lesions to treat.1

    Read more about the trial details and results here.

  • What are the dose strengths of IMLYGIC®?

    IMLYGIC® is provided in single-use vials of 1 mL each in two different dose strengths1: 106 (1 million) plaque-forming units (PFU) per mL (light green cap)—for initial dose only, and 108 (100 million) PFU per mL (royal blue cap)—for all subsequent doses. See how to administer IMLYGIC® here.

  • How can I order IMLYGIC®?

    IMLYGIC® is shipped from select authorized specialty distributors—use the IMLYGIC® Product Ordering Guide to find a qualified distributor. You can find all the details about ordering IMLYGIC® in the storage & handling section of the site.

  • How should IMLYGIC® be stored?

    IMLYGIC® has special storage requirements that you can find in the storage & handling section of this website. Also, Amgen offers the IMLYGIC® freezer program if you need access to an ultra-low freezer. Read more about it here.

  • Are there special handling considerations for IMLYGIC®?

    Yes. Learn more about the special handling considerations for IMLYGIC® here. Please review Prescribing Information prior to handling IMLYGIC®.

  • What is Amgen Assist 360™ and how can it help?

    Amgen Assist 360™ is a comprehensive program provided by Amgen offering the tools, information, and support for Amgen oncology products that make a difference for you and your patients. Learn about Amgen Assist 360™ support here.

  • Who should I contact with a clinical inquiry?

    If you have a clinical inquiry or would like to report an adverse event related to IMLYGIC®, connect online to medical information or call 1‑800‑77‑AMGEN (1‑800‑772‑6436).

  • Who should I contact with a general inquiry that is not listed here?

    Please contact the appropriate Amgen resource using the information found here.

REFERENCES

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
  2. 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.
  3. 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.
  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(suppl Clinical Study Protocol):doi:10.1200/JCO.2014.58.3377.