Novartis claims that the COMBI-d study of 423 patients is longest Ph III survival follow-up to date of BRAF V600E/K mutation-positive melanoma patients who received a targeted combination therapy.
The three-year survival rate was estimated to be 44% for patients receiving the combination therapy, compared with 32% who received Tafinlar alone.
Of those patients still enrolled at three years, 58% were receiving the combination.
Investigator-assessed progression-free survival was the primary endpoint of the study. Secondary endpoints included overall survival (OS), overall response rate, duration of response, and safety.
About 26 patients moved over from the monotherapy group to the combination group after the combination showed a significant OS benefit in a prior analysis.
Novartis global head of oncology development & medical affairs Alessandro Riva said: "This type of treatment approach is not only helping to grow the practice of precision oncology, but has the potential to fundamentally change the way we treat cancer."
Tafinlar and Mekinist target different kinases within the serine/threonine kinase family – BRAF and MEK1/2, respectively – in the RAS/RAF/MEK/ERK pathway, which is implicated in non-small cell lung cancer and melanoma.
The combination, which has been demonstrated to slow tumor growth more than either drug alone, is currently being evaluated in an ongoing clinical trial program across several tumor types.
The safety and efficacy profile of the combination has not yet been established outside of the approved indication.
Tafinlar and Mekinist are also indicated in over 35 countries globally, including the US and European Union, as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Image: Novartis Logo, Basel Headquarters. Photo: courtesy of Novartis AG.