TAFINLAR - MEKINIST (dabrafénib/tramétinib)
Reason for request
Approval of continued reimbursement of the TAFINLAR (dabrafenib) / MEKINIST (trametinib) combination, only in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) carrying a BRAF V600E mutation, in the second-line of treatment or beyond, after failure of the current standard treatments (chemotherapy and/or immunotherapy).
No progress, based on the data currently available.
Role in therapeutic strategy?
Apart from mutations or translocations for which targeted therapies are available, first-line treatment for non-small cell lung cancer is based on immunotherapy with or without platinum-salt-based chemotherapy regardless of BRAF status.
In a retrospective French case-control study, pemetrexed appeared to be the best doublet in terms of survival in BRAF-mutated patients. As a second line treatment, immunotherapy is recommended for patients who have failed to respond to chemotherapy alone. The use of immunotherapy for these patients can be considered under the same conditions as for non-mutated patients. In the ImmunoTarget study, patients with BRAF alteration had a 54% control rate on immunotherapy as a monotherapy, and seemed to be barely affected by PDL1 status. However, there is a clear numerical difference between patients with non-V600E BRAF mutations (median progression-free survival at 4.1 months) and V600E mutations (median progression-free survival at 1.8 months).
Role of TAFINLAR (dabrafenib) / MEKINIST (trametinib) in the treatment strategy:
The combination of TAFINLAR (dabrafenib) and MEKINIST (trametinib) remains an option for second-line treatment and beyond after failure of chemotherapy and/or immunotherapy in adult patients suffering from advanced NSCLC with the BRAF V600E mutation.
The Committee deems that the actual clinical benefit of TAFINLAR (dabrafenib) / MEKINIST (trametinib) remains low only in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as a second-line treatment or beyond, after the failure of current standard treatments (chemotherapy and/or immunotherapy).
Clinical Added Value
|no clinical added value||
Considering the new data added to the submission and based on:
the Committee deems that the clinical added value (CAV) attributed to the TAFINLAR (dabrafenib) / MEKINIST (trametinib) combination in its opinion of 8 June 2020 remains unchanged, i.e. no improvement in clinical added value (CAV V) in the management of patients suffering from NSCLC with a BRAF V600E mutation, as a second-line treatment and beyond, after failure of chemotherapy and/or immunotherapy.