Merck & Co has started the submission process for its much-touted new skin cancer therapy MK-3475 in the US, and says it could complete the application in the first half of this year.
MK-3475 has been awarded breakthrough status by the FDA, so already qualifies for a fast track review that means it could be approved around the end of the year if all goes smoothly with the review process.
The ‘rolling’ Biologics License Application (BLA) is for the use of MK-3475 in patients with advanced melanoma who have previously been treated with Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab), the first drug ever to extend survival in melanoma patients.
MK-3475 – an anti-PD1 therapy – is in a race to market with other candidates in the drug class, including BMS’ nivolumab and Roche’s MPDL3280A. It has already shown positive results on survival in a phase Ib study reported last November, and is also in comparison trials against traditional chemotherapy (phase II) and Yervoy (phase III).
“MK-3475 is a novel immunomodulatory molecule that holds promise for patients with advanced malignancy who now have limited treatment options,” said Merck’s R&D chief Roger Perlmutter.
Anti-PD1 therapies are thought to work by stripping away a molecular mask on tumour cells that help them evade detection by the immune system.
Merck is also looking at MK-3475’s potential in non-small cell lung cancer (NSCLC) and a plethora of other cancer types, and recently set up a dedicated business unit to manage the development of what it clearly sees as one of the brightest hopes in its pipeline.
Some analysts have suggested MK-3475 could eventually achieve sales in the multibillion-dollar range at peak, depending on how it stacks up against rival candidates in the anti-PD1 space.
Merck’s shares closed up 6.5 per cent yesterday on the news amid a flurry of analyst upgrades, although a number of these were prompted by suggestions that the company is considering “strategic options” for its consumer health and veterinary units, with a decision expected before the end of the year. It has been suggested that these options could include an asset swap with Novartis.