▎WuXiEdited by Kant Content Team
Recently, Amgen announced in its Q2 2024 earnings report thatThe regulatory application for the combination therapy of its KRAS G12C inhibitor Lumakras (sotorasib) and EGFR inhibitor Vectibix (panitumumab) has been accepted by the U.S. FDA., used to treat carriers ofKRASG12C-Mutant Metastatic Colorectal Cancer.The FDA also granted this application Priority Review, with an expected completion date of October 17 this year.
The submission of this application is based on the positive results of the Phase 3 clinical trial CodeBreaK 300. Previously published results in The New England Journal of Medicine showed,At a median follow-up time of 7.8 months, the median progression-free survival (PFS) was 5.6 months for patients in the combination therapy group receiving 960 mg of Lumakras with Vectibix, 3.9 months for those in the group receiving 240 mg of Lumakras with Vectibix, and 2.2 months for the then-standard treatment group.960 mg Lumakras combination therapy reduced the risk of disease progression or death by 51% (HR=0.49, 95% CI, 0.30-0.80, p=0.006) compared to standard treatment. The 240 mg Lumakras combination therapy group reduced the risk of disease progression or death by 42% (HR=0.58, 95% CI, 0.36-0.93, p=0.03).Moreover, the objective response rate (ORR) was 26.4% in the 960 mg Lumakras combination therapy group, 5.7% in the 240 mg Lumakras combination therapy group, and 0 in the standard therapy group.
Lumakras is the first KRAS G12C inhibitor to receive FDA approval in the United States., representing a significant breakthrough in targeting the difficult-to-drug KRAS. Amgen is currently conducting the Phase 3 clinical trial CodeBreaK 202, evaluating Lumakras in combination with chemotherapy as a first-line treatment for patients withKRASEfficacy of G12C Mutation, PD-L1 Negative Advanced Non-Small Cell Lung Cancer.
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[1] AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS. Retrieved August 7, 2024, from https://www.amgen.com/newsroom/press-releases/2024/08/amgen-reports-second-quarter-2024-financial-results[2] Fakih et al., (2023). Sotorasib plus Panitumumab in Refractory Colorectal Cancer with Mutated KRAS G12C. NEJM, DOI: 10.1056/NEJMoa2308795Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a regular hospital.Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the "WuXi AppTec" WeChat Official Account to obtain reprint guidelines.
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