Study finds Amgen drug shrinks tumors in lung cancer patients with KRAS gene mutation


By Deena Beasley

An experimental Amgen Inc drug that targets a specific genetic mutation shrank tumors in 32% of advanced lung cancer patients and 7% of those with colon cancer, according to data from an early-stage trial presented on Sunday.

The median length of time that patients given the drug sotorasib lived before their disease worsened was 6.3 months for lung cancer patients and 4 months for colorectal cancer patients, the company said. Participants in the 129-patient study were followed for a median of 11.7 months.

Patients in the Phase I trial involving several types of cancer were treated with once daily sotorasib. The oral medication is designed to target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.

The KRAS mutation is also found in 1% to 3% of colorectal and other cancers. Sotorasib is part of a growing trend of precision medicines that target gene mutations driving cancer regardless of which organ the disease originated.

Out of 59 NSCLC patients, 32% had a partial response to the drug – tumor shrinkage by at least 30% – and 88% had either a lesser response or stable disease. For the 42 patients with colorectal cancer, 7% had tumor shrinkage and 74% had stable disease.

“These are patients that have very few options,” said Gregory Friberg, Amgen’s head of oncology global development. “They were on a third or fourth line of therapy.”

The company expects by the end of this year to have results from a mid-stage lung cancer trial that could be used to seek U.S. approval of sotorasib.

Analysts are keen to see how rival KRAS drugs, including data expected later this year from Mirati Therapeutics Inc, will stack up against sotorasib.

Researchers, who presented the Amgen data at a virtual meeting of the European Society for Medical Oncology, said responses were also seen with pancreatic, endometrial, and appendix cancers and melanoma.

Adverse side effects occurred in about 12% of trial patients, researchers reported.

Amgen is also testing the drug in combination with other medications, including Merck & Co’s immunotherapy Keytruda.

(Reporting By Deena Beasley; Editing by Bill Berkrot)

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