BRAFTOVI / MEKTOVI (encorafenib / binimetinib) - Non-small cell lung cancer

The clinical benefit of the BRAFTOVI (encorafenib) 75 mg hard capsules and MEKTOVI (binimetinib) 15 mg and 45 mg film-coated tablets combination is low in the second-line treatment of advanced NSCLC with a BRAF V600E mutation, following the failure of chemotherapy and/or immunotherapy.

Considering:

• the results of the phase 2, non-comparative PHAROS study conducted in 39 patients having demonstrated an IRR-assessed ORR of 2% (95% CI [30.1; 62.8]), including 10.3% complete responses and 35.9% partial responses,
• the absence of sufficiently robust comparative data enabling the size effect of the BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) combination to be estimated compared to clinically relevant comparators, despite these being available at the time of initiation of the PHAROS study:
  • immunotherapy, combined or otherwise with chemotherapy,
  • the TAFINLAR (dabrafenib) and MEKINIST (trametinib) combination, which has an identical mechanism of action to the BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) combination, and had an MA at the time of initiation of the PHAROS study,
• the still inadequately established prognostic value of BRAF V600 mutation in NSCLC,
• the absence of quality of life data, not assessed in the PHAROS study,
• and the safety profile marked by;
  • an incidence of grade ≥ 3 adverse events of 46.2%,
  • an incidence of serious adverse events of 43.6%,
  • an incidence of adverse events having resulted in death of 2.6%,
  • and the occurrence of an adverse event of particular interest in 72% of patients for binimetinib and 48.7% for encorafenib,

the Committee deems that the BRAFTOVI (encorafenib) 75 mg hard capsules and MEKTOVI (binimetinib) 15 mg and 45 mg film-coated tablets combination provides no clinical added value (CAV V) in the management of patients with NSCLC with a BRAF V600E mutation, as second or later-line treatment following the failure of chemotherapy and/or
immunotherapy.