Amgen says Lumakras cuts risk of lung cancer progression by 34 per cent

Amgen’s Lumakras pill reduced the risk of disease progression in patients with advanced lung cancer by 34 per cent compared with chemotherapy in a clinical trial, the company said yesterday.

There was no significant difference in the overall survival between the two treatments in the confirmatory study required by the US regulators as a condition of accelerated approval for Lumakras. But Amgen said the trial was not designed to detect a survival difference.

The company is also testing whether the drug could be effective against lung cancer earlier in the disease, and said last month a small study of Lumakras combined with immunotherapy found high rates of liver toxicity and that further study was needed.

More detailed results from the 345-patient study, including median progression-free survival – the length of time until the cancer begins to worsen – will be presented at the annual meeting of the European Society for Medical Oncology (ESMO) in Paris.

Amgen said 33 per cent of Lumakras trial patients experienced serious side effects such as diarrhoea and elevated liver enzymes, compared with 40 per cent of chemotherapy patients.

The medication is designed to target a mutated form of a gene known as KRAS that occurs in about 13  per cent of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumours.

Lumakras was approved by the US Food and Drug Administration (FDA) last year under an accelerated pathway for advanced lung cancer patients with KRAS mutations whose disease has worsened after treatment with chemotherapy or other medicines.

The agency also asked Amgen to study a lower dose of Lumakras, known chemically as sotorasib. The company said those results are expected in the fourth quarter of this year.

The FDA is slated to make an approval decision on a potential rival KRAS-targetting drug, Mirati Therapeutics’s adagrasib, by mid-December.

Mirati in May said adagrasib shrank tumours in 44 per cent of advanced lung cancer patients in clinical trials, but also caused serious side effects in 43 per cent of them.

At the ESMO meeting this week, Amgen is also presenting early data from a trial of Lumakras in combination with other cancer drugs for patients with colorectal cancer.

Edits by EP News Bureau