Talimogen laherparepvec (1) – Imlygic®

• Clinical trials
  • The aim of this study was to investigate the efficacy and safety of intralesional treatment with talimogen laherparepvec compared with subcutaneously administered granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with unresectable melanoma.
  • The analyses presented are limited to the patient population of study patients with stage IIIB, IIIC and IVMIa disease, for whom marketing authorisation was subsequently granted.

a) Previously untreated patients with a BRAF V600-mutated tumour

• The additional benefit is not proven.
• On the basis of the study presented, it is not possible to make comparative statements regarding additional benefit, either for previously untreated patients with a BRAF V600-mutated tumour or for patients with a BRAF V600 wild-type tumour, in relation to the respective appropriate comparator therapy determined by the G-BA, namely vemurafenib and ipilimumab, respectively.
• Nor is a descriptive comparison of the results of the OPTiM study with various pivotal studies on active ingredients authorised for the therapeutic indication and commonly used in therapy adequate.
• Taking into account the available targeted therapy options for treating the different patient populations within the indication, it is therefore not possible, on balance, to establish any additional benefit for either of the two patient populations compared with the appropriate therapies in the therapeutic indication, as determined by the currently recognised state of medical knowledge.

b) Previously untreated patients with a BRAF V600 wild-type tumour

• The additional benefit is not proven.
• On the basis of the study submitted, it is not possible to make comparative statements regarding additional benefit, either for previously untreated patients with a BRAF V600-mutated tumour or for patients with a BRAF V600 wild-type tumour, compared with the respective appropriate comparator therapy determined by the G-BA, namely vemurafenib and ipilimumab, respectively.
• Nor is a descriptive comparison of the results of the OPTiM study with various pivotal studies on active ingredients authorised for the therapeutic indication and commonly used in clinical practice adequate.
• Taking into account the available targeted therapy options for treating the different patient populations within the indication, it is therefore not possible, on balance, to establish any additional benefit for either of the two patient populations compared with the appropriate therapies in the therapeutic indication, as determined by the currently recognised state of medical knowledge.

c) Previously treated patients

• An additional benefit is not proven.
• Furthermore, the comparator GM-CSF used in the OPTiM registration trial is not part of a patient-specific treatment regimen as determined by the treating doctor.
• The study cannot therefore be used to assess the additional benefit of talimogen laherparepvec in previously treated patients with malignant melanoma.
• There is no marketing authorisation for a medicinal product containing the active ingredient GM-CSF, neither for this indication nor in general.
• GM-CSF is not currently standard practice in clinical care and was not so at the time the study was conducted.
• The experts consulted by the EMA as part of the authorisation procedure also expressed criticism of the chosen comparator.
• Consequently, even for pre-treated patients, it is not possible to establish any additional benefit compared with the therapies considered appropriate for the therapeutic indication according to the currently recognised state of medical knowledge.

Courtesy translation only, please refer to the German original.