In a late-stage study, a combination of experimental drugs—encorafenib and binimetinib (Array BioPharma, Inc.)—kept patients with advanced melanoma associated with a common gene mutation alive for nearly three years and twice as long as rival medicine vemurafenib (Zelboraf, Roche), according to a Reuters report.
The oral drugs encorafenib and binimetinib are awaiting an FDA approval decision by June 30 based on promising data showing their ability to stall disease worsening (progression-free survival [PFS]). European regulators are also reviewing the treatment. However, overall survival is seen as the gold standard for cancer treatments, and the new data is likely to significantly enhance approval and eventual sales prospects, Reuters said.
The Array combination—450 mg of encorafenib once daily and 45 mg of binimetinib twice a day—led to median overall survival (OS) of 33.6 months in patients with advanced melanoma with a BRAF mutation, meaning half the patients were still alive nearly three years after treatment. That compared with median OS of 16.9 months for patients in the phase 3 study who received vemurafenib.
Advanced melanoma is the deadliest form of skin cancer. About half of the estimated 200,000 new melanoma cases diagnosed worldwide each year carry BRAF mutations.
“There remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival,” Keith Flaherty, a lead investigator of the study from Massachusetts General Hospital Cancer Center in Boston, said in a statement. “This data suggests that the combination of encorafenib and binimetinib may have the potential to become a meaningful new therapy for patients with advanced BRAF-mutant melanoma.”
In a pivotal trial of a similar, already approved combination from Novartis, nearly 30% of patients were still alive five years after being treated with Tafinolar and Mekinist.
PFS and safety data from the Array trial were previously announced. The medicines are being co-developed by privately held French pharmaceuticals group Pierre Fabre.
Source: Reuters; February 6, 2018.