European regulators have expanded the scope of Novartis’ Tafinlar/Mekinist combination to include the treatment of patients with a certain form of lung cancer.
Tafinlar (dabrafenib) and Mekinist (trametinib) can now be prescribed across EU member states to treat BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC), offering the first targeted treatment option for this patient population.
The decision is based on safety and efficacy data from a Phase II, three-cohort, multicenter, non-randomised and open-label study including patients with stage IV BRAF V600E mutant NSCLC.
In the trial, 36 treatment-naïve patients receiving 150mg of Tafinlar twice daily and 2mg of Mekinist once daily demonstrated an objective response rate of 61.1 percent. In this population, 68 percent of patients had not progressed after nine months.
In the previously treated population receiving the same dosage, patients demonstrated an ORR of 66.7 percent. The response was durable with a median DoR reaching 9.8 months, the from noted.
The most common adverse events with an incidence of more than 20 percent were pyrexia, nausea, vomiting, peripheral oedema, diarrhoea, dry skin, decreased appetite, asthenia, chills, cough, fatigue, rash, and dyspnoea.
Tafinlar/Mekinist is also being assessed for BRAF V600-positive NSCLC by US regulators under a priority review, and the combination is already approved in several regions - including the US and EU - as a treatment for patients with unresectable or metastatic melanoma whose tumours test positive for the BRAF V600 mutation.