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Amgen reveals more data on KRAS drug

Unveiled an overall disease control rate of 100%

Amgen

Amgen has revealed more data for its pathfinder KRAS inhibitor AMG 510, building its case for the drug as a treatment for KRAS G12C-positive non-small cell lung cancer (NSCLC).

AMG 510 became the first KRAS inhibitor to show activity in a 35-patient phase 1 trial presented at this year’s ASCO congress, and an update from the trial was reported at the World Conference on Lung Cancer over the weekend.

The results show that seven (54%) of 13 NSCLC patients with the G12C mutation experienced a partial response at a dose of 960 mg, considered to be the most effective, with the remaining six (46%) all having stable disease.

The partial response rate was a little lower than some analysts had been predicting, but the overall disease control rate of 100% is higher than the earlier data readout. It suggests that the drug is working as expected in these very sick patients, with no dose-limiting toxicities or treatment discontinuations.

It is estimated that around 14% of NSCLC adenocarcinoma patients and roughly 5% of colorectal cancer patients have the KRAS G12C mutation. Amgen is due to report preliminary data in colorectal cancer patients later this month at the ESMO meeting.

Amgen is leading the field among companies developing inhibitors of KRAS, an oncogene that is implicated in around a third of all human cancers.

It has been intensely studied as a potential drug target for around three decades, but efforts have been met with such little success – mainly because the protein lacks traditional small molecule binding pockets – that it came to be considered an 'undruggable' target.

Amgen bucked the trend by discovering a previously missed groove on the protein surface that could be targeted by an inhibitor.

The new data is still very early of course, but it keeps the AMG 510 programme on track and clears ground between Amgen and its nearest challengers in the KRAS inhibitor race, which include Mirati, Boehringer Ingelheim, Johnson & Johnson/Wellspring, Merck/Moderna and AstraZeneca/Ionis.

Mirati’s MRTX849 also targets G12 and is being evaluated in a phase 1/2 trial due to generate results later this year.

Amgen is now moving ahead quickly with other studies of AMG 510, including a phase 2 monotherapy trial and phase 1 combination studies intended to guard against the possibility that tumours may develop resistance to the drug, an almost inevitable situation with highly targeted cancer drugs.

Article by
Phil Taylor

9th September 2019

From: Research

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