Amgen grabs EU approval for pathfinder KRAS drug Lumykras

Amgen now has regulatory approval on both sides of the Atlantic for Lumykras, the culmination of many years of effort to bring a drug to market that inhibits KRAS – a cancer target that for a long time was considered "undruggable".

The European Commission has approved Lumykras (sotorasib) as a monotherapy for adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one earlier line of systemic therapy – a use cleared last May in the US where the drug is known as Lumakras.

The drug has also been approved in Great Britain, reaching the market armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE.

KRAS mutations are seen in around a quarter of NSCLC tumours, with KRAS G12C mutations in particular found in around 13% of cases.

Lumykras is the first KRAS inhibitor to be approved for marketing, making its debut in the US last year at a price of $17,900 per month – equivalent to around $215,000 per year – which is in the same ballpark as other targeted cancer drugs.

The EU approval is based on the phase 2 CodeBreak 100 study in 733 subjects, which found that treatment with Lumykras was associated with a 37% objective response rate (ORR), defined as a 30% or greater reduction in tumour volume, when used as a second-line therapy for KRAS G12C-mutated NSCLC after chemotherapy and/or immunotherapy.

Patients treated with the orally-active, once-daily drug had a median duration of response of 11.1 months, so had almost a year more before disease progression.

Amgen is running a confirmatory phase 3 trial called CodeBreak 200 that is comparing Lumakras to the chemotherapy agent docetaxel in previously-treated patients with KRAS G12C-mutated NSCLC, with a readout due later this year.

Analysts have suggested that Lumykras could become a $1 billion-plus product if Amgen can extend the label for the drug into the first-line NSCLC setting and get approval for other KRAS-mutated tumour types such as colorectal and pancreatic cancers.

In the third quarter of 2021, Amgen reported $36 million in sales for the drug in the US, saying it had got off to a "strong start".

The EU approval extends Amgen's lead over its closest competitor in the KRAS inhibitor category – Mirati – which is developing a candidate called adagrasib and is working towards a US approval and launch for the drug later this year.

Merck & Co and Boehringer Ingelheim are among other drugmakers with KRAS inhibitors in their cancer pipelines.