INDICATION & LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery...READ MORE

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HYPOTHETICAL PATIENT PROFILES: HENRY, PATRICIA, AND STANLEY

The following are hypothetical patient profiles. All images and photographs are representative and are not of actual IMLYGIC® patients.

This section is intended to help you determine the types of patients who may be appropriate for treatment with IMLYGIC®.1

Henry—Stage IIIB
Photograph of a hypothetical patient with Stage IIIB melanoma

Henry

A 60-year-old Caucasian patient with unresectable in-transit recurrence (Stage IIIB)1

  • Married, 3 children
  • Full-time operator of a hardware store
Patricia—Stage IIIC
Photograph of a hypothetical patient with Stage IIIC melanoma

Patricia

A 37-year-old Caucasian patient with unresectable nodal recurrence (Stage IIIC)1,3

  • Single, 2 young children
  • High school substitute teacher
Stanley—Stage IVM1a
Photograph of a hypothetical patient with Stage IVM1a melanoma

Stanley

A 67-year-old Caucasian patient with mixed response to systemic immunotherapy (Stage IVM1a)1

  • Widower, 7 grandchildren

18 months ago:

  • Diagnosed with T3aN0M0 Stage IIA melanoma2,3
  • Primary melanoma on left shin
  • Breslow thickness 3.5 mm without ulceration
  • SLNB negative

Primary Treatment: Wide local excision followed by observation (no adjuvant treatment)3

Close-up of Stage IIIB melanoma lesions

Today:

Recurrent (Stage IIIB)2

  • Presents with in-transit recurrence approximately 18 months after initial diagnosis
  • Additional clinical considerations: slow-progressing disease, LDH not elevated; BRAF wild type; ECOG PS 0
  • CT scan of chest, abdomen, and pelvis revealed no metastatic disease

Unresectable

  • Numerous new lesions, extending from his left shin to his thigh

Close-up of Stage IIIB melanoma lesions

Injectable

  • Cutaneous lesions are accessible for injection1

ECOG PS = Eastern Cooperative Oncology Group Performance Status; LDH = lactate dehydrogenase; SLNB = sentinel lymph node biopsy.

18 months ago:

  • Diagnosed with T4bN0M0 Stage IIC melanoma2,3
  • Primary superficial spreading melanoma on upper-mid back
  • Breslow thickness 6.5 mm with ulceration
  • SLNB in left axilla negative

Primary Treatment: Surgical excision with skin graft; adjuvant interferon treatment for 1 year3

Close-up of Stage IIIC melanoma lesions; Alt tag: PET scan demonstrating Stage IIIC melanoma

Today:

Recurrent (Stage IIIC)2

  • Presents with palpable mass in left axilla consistent with recurrence 6 months after completion of adjuvant treatment
  • Additional clinical considerations: slow-progressing disease; low disease burden; BRAF wild type; ECOG PS 0

Unresectable

  • PET scan shows axillary lymph node metastasis with involvement of neurovascular bundle with no metastases in other organs

Close-up of Stage IIIC melanoma lesions; Alt tag: PET scan demonstrating Stage IIIC melanoma

Injectable

  • Nodal lesions are accessible for injection using ultrasound guidance1

CT = computed tomography; ECOG = Eastern Cooperative Oncology Group Score; PET = positron emission tomography; SLNB = sentinel lymph node biopsy.

4 Years Ago:

  • Diagnosed with T3bN1bM0 Stage IIIC melanoma2
  • Primary melanoma on right posterior scalp
  • SLNB positive followed by posterior node dissection (1/33 positive total)
  • PET/CT and MRI negative (revealed no metastatic disease)

Primary Treatment: Wide local excision, posterior node dissection; adjuvant biochemotherapy3

PET scan demonstrating and close-up of Stage IVM1a melanoma

1 Year Ago:

Recurrent (STAGE IVM1a)2

  • Presents with palpable mass consistent with local recurrence and 2 new right flank lesions 3 years after primary treatment
  • PET shows progression into 2 supraclavicular nodes
  • Medical history does not reveal any autoimmune diseases
  • Additional clinical considerations: Biopsy confirms BRAF Wild Type melanoma; LDH not elevated; ECOG PS 1
  • Received treatment with systemic immunotherapy3
PET scan demonstrating Stage IVM1a melanoma

Today:

Recurrent (Stage IIIC)

  • Stage IVM1a disease remains following mixed response to previous systemic immunotherapy1
  • PET scan shows response in supraclavicular nodes with no metastatic disease in other organs
  • Scalp and flank lesions increased in size
  • Appearance of new lesions on posterior neck and lower back
  • Discontinued systemic immunotherapy for melanoma due to disease progression
PET scan demonstrating Stage IVM1a melanoma

Unresectable

  • Resection may not be surgically curative

Injectable

  • Increasing local tumor burden with addition of new lesions

CT = computed tomography; ECOG = Eastern Cooperative Oncology Group Score; LDH = lactate dehydrogenase; MRI = magnetic resonance imaging; PET = positron emission tomography; SLNB = sentinel lymph node biopsy.

Lesion Tracking Sheet

The Lesion Tracking Sheet can help you document treatment of melanoma lesions.

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REFERENCES

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
  2. Balch CM, Gershenwald JE, Soong S, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009;27:6199-6206.
  3. American Cancer Society. Melanoma Skin Cancer. http://
    www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf. Accessed January 10, 2017.

IMPORTANT SAFETY INFORMATION

Contraindications
  • Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
  • Do not administer IMLYGIC® to pregnant patients.
Warnings and Precautions
  • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
  • Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
  • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
  • Herpetic infections: Herpetic infections (including but not limited to cold sores and herpetic keratitis) and serious cases of disseminated herpetic infections have been reported in IMLYGIC-® treated patients, including fatal disseminated herpetic infection in the immunocompromised patient population. Immunocompromised patients may be at increased risk of life-threatening disseminated herpetic infection. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
  • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
  • IMLYGIC® is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
  • Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC® treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
  • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (eg, previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
  • Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC®. Consider the risks and benefits of IMLYGIC® before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
  • Plasmacytoma at the Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
  • Obstructive Airway Disorder: Obstructive airway disorder has been reported following IMLYGIC® treatment. Use caution when injecting lesions close to major airways.
  • Hepatic Hemorrhage from Transcutaneous Intrahepatic Route of Administration: IMLYGIC is not indicated for transcutaneous intrahepatic route of administration. In clinical studies, cases of hepatic hemorrhage resulting in hospitalization and death have been reported in patients receiving transcutaneous intrahepatic IMLYGIC injections
Adverse Reactions
  • The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC®-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see full Prescribing Information and Medication Guide for IMLYGIC®.

INDICATION

IMLYGIC® is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.

Do not administer IMLYGIC® to pregnant patients.

Warnings and Precautions

Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should

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