Array’s melanoma therapy blasts Roche’s out of water
pharmafile | February 7, 2018 | News story | Research and Development | Array Biopharma, Pierre Fabre, Roche, biotech, drugs, melanoma, pharma, pharmaceutical
Array Biopharma suffered a serious knock back in early 2017 when its plan to commercialise its drug, binimetinib, were derailed by FDA scepticism of the strength of its data for the treatment of NRAS+ melanoma.
It has seemingly bounced back with data in the treatment of BRAF-mutant melanoma, when binimetinib combined with encorafenib resulted in an improvement to median overall survival by 33.6 months.
This compared extremely favourably to treatment with Roche’s vemurafenib when it was used as a monotherapy, which was only able to boost OS by 16.9 months.
The positive results add to previous results that showed the combination treatment was able to boost median progression-free survival by 14.9 months, compared against 7.3 months on patients taking vemurafenib.
“We are excited to report these overall survival results from the Columbus trial,” said Victor Sandor, Chief Medical Officer, Array BioPharma. “This encouraging overall survival finding further validates previously reported median progression-free survival and overall response rate results, and taken together with the attractive tolerability profile, these data suggest that the combination of encorafenib with binimetinib has the potential to become a promising new treatment option for these patients.”
Array had already submitted applications to the FDA, the EMA, as well as Swiss and Australian regulators.
It is likely that the improvement to PFS may have been enough to secure approval but with the outsized benefits seen in OS, approval looks to be a formality across the board.
In addition, as mentioned by Sandor, the safety profile of the combination drug looks to be favourable when compared with vemurafenib. Both treatments experienced similar levels of Grade 3/4 adverse events – at 58% for the combo treatment and 63% for vemurafenib.
Array has been developing the treatments alongside Pierre Fabre and both companies will take a split of the global market. Array will be responsible for commercialisation in the US and Canada, while Pierre Fabre will take the European market and the rest of the world, barring Japan and South Korea – granted to Ono Pharmaceutical.
The decision on the treatment from the FDA is expected by June.
Ben Hargreaves
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