A targeted combination therapy being developed by Novartis as adjuvant treatment for patients with a certain type of melanoma has been assigned breakthrough designation in the US.
The therapy, which combines Tafinlar (dabrafenib) in combination with Mekinist (trametinib), has the potential to become the first adjuvant treatment specifically for patients with stage III melanoma with a BRAF V600 mutation.
The breakthrough designation - designed to expedite the development and review medicines that target serious or life threatening conditions and have the potential to offer substantial benefit over existing therapies - is based on mid-stage clinical data showing an improvement in relapse-fee survival.
According to results of the Phase III COMBI-AD study, after a median follow-up of 2.8 years, treatment with the combination therapy significantly reduced the risk of disease recurrence or death by 53 percent versus placebo in patients with stage III BRAF V600E/K mutation-positive melanoma treated after complete surgical resection .
On the safety side, side effects were consistent with other Tafinlar plus Mekinist studies, and no new safety signals were reported. Of patients treated with the combination, 97 percent experienced an AE; 41 percent had grade 3/4 AEs and 26 percent had AEs leading to treatment discontinuation (vs. 88 percent, 14 percent and 3 percent, respectively, for placebo).
"There is a need for more effective treatment options for stage III melanoma patients at a high risk of recurrence following surgical resection," said Samit Hirawat, who heads up Global Drug Development at Novartis Oncology. "We thank the FDA for recognising the scientific advancement Tafinlar and Mekinist may provide in this adjuvant setting."
Combination use of Tafinlar plus Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the US, EU, Australia, Canada and other countries. The combination is also cleared for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation in the US and advanced NSCLC with a BRAF V600 mutation in the EU.