Amgen Testing Program Could Identify NSCLC Patients With KRAS Biomarker

Biomarker status can help clinicians and patients make informed, personalized treatment decisions, whether the choice is an FDA-approved targeted therapy or a clinical trial.

Amgen launched a program this week that could help more patients with nonsmall cell lung cancer (NSCLC) gain access to biomarker testing—and also identify patients with a key biomarker tied to the pharma giant’s investigational therapy.

Biomarker Assist, announced Monday, consists of two programs, the Next Generation Sequencing (NGS) Affordability Program and the KRAS Single Gene Test Program. Both are scheduled to continue through the end of this year.

Clinical guidelines, including those from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the American Society of Clinical Oncology call for biomarker testing of multiple genes simultaneously in patients diagnosed with advanced NSCLC regardless of clinical characteristics such as age, race or smoking status. Biomarker status can help clinicians and patients make informed treatment decisions, whether the choice is an FDA-approved targeted therapy or a clinical trial.

“Approximately half of all patients with nonsmall cell lung cancer have oncogene biomarkers, yet despite the integral role that biomarkers play in lung cancer to identify patients who may benefit from targeted therapies, many patients are not tested," said Darryl Sleep, MD, chief medical officer and senior vice president of Global Medical at Amgen.

According to the Amgen website, the Biomarker Assist NGS Affordability Program can help eligible, commercially insured patients with NSCLC reduce out-of-pocket costs for their NGS biomarker test, including deductible, co-insurance, and co-payment, up to a maximum of $1,000. There are no income requirements.

The KRAS single gene test program is for patients with of any insurance type—commercial, Medicare, Medicaid, or uninsured. The healthcare provider submits a request form before the test is performed, and there is no cost to the patient.

While commercially insured patients could get help with NGS, including KRAS G12C, a broader group of patients could get KRAS testing, and both programs would potentially identify patients with the KRAS G12C biomarker.

Amgen is currently investigating sotorasib, a KRAS G12C inhibitor. In January, results from the phase 2 cohort of the CodeBreaK 100 study showed that 37.1% of patients with advanced NSCLC responded to sotorasib, with a median duration of response of 10 months. The median tumor shrinkage was 60%; 43 patients had partial response and three had a compete response.

David M. Reese, M.D., Amgen’s executive vice president of research and development, noted at the time that KRAS has been an elusive target for decades, and "Patients with advanced non-small cell lung cancer who have failed first-line treatment face extremely poor outcomes with limited treatment options available.”