KRASG12C-Mutant NSCLC: AMG510 Phase I Efficacy and Safety
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Phase I Trial Results
- October 10, 2019
On September 9, 2019, Amgen announced Phase I trial results of AMG510 (sotorasib), an oral KRAS G12C inhibitor, in previously treated KRASG12C-mutant solid tumors (n=34) with focus on NSCLC subset (n=23).
Molecular Background
KRAS gene family mutations represent the most common genetic alterations in human cancer. KRASG12C mutation incidence:
- Non-small cell lung cancer: ~13%
- Colorectal cancer: 3-5%
- Advanced solid tumors: 1-2%
- United States: ~30,000 annual diagnoses
KRAS mechanism and therapeutic targeting remained unclear until AMG510 development, addressing previously undruggable mutation.
Trial Design
Patient Population: Previously treated KRASG12C-mutant solid tumors (n=34)
Treatment: AMG510 800-960 mg once daily oral monotherapy
Primary Endpoint: Safety
Secondary Endpoints: Objective response rate, response duration
Efficacy Results (n=23 NSCLC-evaluable)
Objective Response Rate (960 mg cohort): 54% (n=13/24)
- Partial response: 54%
Disease Control Rate: 100%
- Partial response: 54%
- Stable disease: 46%
Safety Results (n=34 evaluable)
- Grade 1-2 adverse events: 26.5% (n=9)
- Grade 3 toxicities: 3 patients (anemia, diarrhea)
- Grade 4+ toxicities: None
- Dose-limiting toxicities: Zero
- Treatment discontinuations due to toxicity: Zero
Clinical Conclusions
AMG510 monotherapy meets clinical need for previously treated KRASG12C-mutant NSCLC, with favorable efficacy and safety supporting further clinical development.
Data Source
Amgen WCLC 2019: Novel KRAS G12C Inhibitor Clinical Data
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