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Results From Phase 2 CodeBreaK 100 Show LUMAKRAS™ (sotorasib) Is The First And Only KRAS G12C Inhibitor With Overall Survival Data

Published: 2021-06-04 20:00:00 ET

LUMAKRAS Shows Median Overall Survival of 12.5 Months in Patients With Previously Treated Non-Small Cell Lung Cancer

Data Confirms Rapid, Deep, and Durable Responses With Median Duration of Response of 11.1 Months

Data Presented at ASCO 2021 and Simultaneously Published in New England Journal of Medicine

THOUSAND OAKS, Calif., June 4, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today presented data on overall survival, a secondary endpoint, from the Phase 2 results of the CodeBreaK 100 clinical study for LUMAKRASTM (sotorasib) in previously treated patients with non-small cell lung cancer (NSCLC) during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. These data were also simultaneously published in the New England Journal of Medicine (NEJM). The publication includes mature overall survival and duration of response data, and results from subgroup and exploratory biomarker analyses.

LUMAKRAS shows a median overall survival (OS) of 12.5 months among 124 evaluable patients, the majority of which were previously treated with both platinum-based chemotherapy and immunotherapy (81%) (data cutoff of March 15, 2021). The results confirmed an objective response rate (ORR) of 37.1%, duration of response (DoR) of 11.1 months and disease control rate (DCR) of 80.6%, with an additional patient achieving complete response (bringing the total to four complete responses and 42 partial responses) compared to previously reported results. The data published in NEJM are updated from results presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) held in January 2021 and are based on a longer follow-up time of 15.3 months.

"Patients with KRAS G12C-mutated non-small cell lung cancer face poor outcomes so we are pleased with these overall survival results and the impact LUMAKRAS may have for patients with this devastating mutation," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The results published in the New England Journal of Medicine further confirm the deep and durable responses we have seen with LUMAKRAS throughout the CodeBreaK clinical trial program, the most advanced KRAS G12C clinical trial program with the longest follow-up."

In exploratory analyses, tumor response to LUMAKRAS was consistently observed across a range of biomarker subgroups, including patient subgroups stratified by baseline PD-L1 expression levels and those with STK11 mutation. In the patient subsets separated by baseline PD-L1 expression (n=86), response and tumor shrinkage were observed across the range of baseline PD-L1 expression levels, with the response rate of 48% for the PD-L1 negative group (TPS

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.