It is a measure of the importance of its new lung cancer drug MK-3475 that Merck & Co is trumpeting the results of a small phase Ib trial presented at a medical conference yesterday.
The results of the extension study show that MK-3475 – an antibody targeting the cellular immune ‘switch’ programmed death -1 (PD-1) – was able to achieve a 24 per cent objective response rate after nine months when given at a dose of 10mg/kg every three weeks to 38 patients with non-small cell lung cancer (NSCLC).
PD-1 is attracting a lot of attention in cancer as drugs that inhibit the T cell co-receptor are thought to restore the natural ability of the immune system to recognise and target cancer cells.
Merck is vying alongside other pharma companies – including Bristol-Myers Squibb (BMS) with its nivolumab candidate, Roche with MPDL320A and AstraZeneca with MEDI4736 and recently-acquired AMP-514 – to be the first to bring a PD-1-targetting drug to market.
Earlier results from the phase Ib study underpinned Merck’s decision to advance MK-3475 into phase II/III testing earlier this year, with a broad development programme spanning bladder, colorectal, head and neck, melanoma, non-small cell lung and triple negative breast cancer.
Merck sees MK-3475 as its number one research priority at a time when it has just started a fresh round of cutbacks to reduce costs by $2.5bn a year, alongside a major reworking of its R&D operations after a series of late-stage pipeline failures and delays including osteoporosis drug odanacatib, anaesthesia drug sugammadex and new insomnia candidate suvorexant.
The company said yesterday it was setting up a dedicated business unit to manage the development of the product and other new candidates in its immunomodulatory programme, which may be an attempt to close the gap on BMS which already has three studies of nivolumab ongoing in melanoma, NSCLC and kidney cancer.
Current analyst estimates see nivolumab reaching market first with peak sales of around $1bn, with MK-3475 launched a little later with sales potential in the order of $500m a year.
MK-3475 was previously known as lambrolizumab but a new name is currently under review. The drug has been granted breakthrough status by the US FDA as a treatment for melanoma.