An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma

Inclusion Criteria:

1. Previously participated in protocol 005/05 (NCT00769704) and:

1. received the maximum number of talimogene laherparepvec treatment injections or
cycles of GM-CSF allowable for that patient on study 005/05, or

2. new injectable lesion(s) appeared after previous resolution of all injectable
disease while on study 005/05. New injectable lesions must have appeared within
≤ 12 months from the End of Treatment visit on the 005/05 study.

2. In the opinion of the investigator and the sponsor's medical monitor further
treatment is warranted [e.g., those patients who do not have clinically relevant
progressive disease (PDr)].

3. Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1.

4. For patients randomized to talimogene laherparepvec only: Injectable disease (i.e.
suitable for direct injection or through the use of ultrasound guidance) defined as
at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no
minimum size for injection.

Exclusion Criteria:

1. Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity
related to talimogene laherparepvec of any organ system (with the exception of
injection site reactions, fever and vomiting).

2. History of Grade 3 fatigue lasting > 1 week while on talimogene laherparepvec
treatment.

3. History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.

4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other
talimogene laherparepvec related non-hematological toxicities while on talimogene
laherparepvec treatment that required a dose delay or discontinuation of talimogene
laherparepvec therapy.

5. PDr while participating in study 005/05

6. Patient requested to be withdrawn from study 005/05 or was unable to comply with the
demands of the 005/05 trial.

7. At the discretion of the investigator, patient was withdrawn from the 005/05 trial.