KRYSTAL-1
KRYSTAL-1 is a Phase 1/2 clinical trial investigating the selective KRAS G12C inhibitor adagrasib (MRTX849) in patients with advanced solid tumors.
๐ฌ General Information
- Drug: Adagrasib (MRTX849)
- Trial Phase: Phase 1/2
- Target Mutation: KRAS G12C
- Tumor Types Studied:
- Colorectal Cancer (CRC)
- Non-Small Cell Lung Cancer (NSCLC)
- Other solid tumors
๐งช Results in Colorectal Cancer (CRC)
Adagrasib Monotherapy
- Objective Response Rate (ORR): 19%
- Median Progression-Free Survival (PFS): 5.6 months
- Median Overall Survival (OS): 19.8 months
Adagrasib + Cetuximab Combination
- ORR: 34%
- Disease Control Rate (DCR): 85.1%
- Median Duration of Response: 5.8 months
- Median PFS: 6.9 months
- Median OS: 15.9 months
- Grade 3โ4 Treatment-Related Adverse Events: 27.7%
- Grade 5 Events: None reported
๐ซ Results in Non-Small Cell Lung Cancer (NSCLC)
- ORR: 43%
- Median Duration of Response: 8.5 months
- Median PFS: 6.5 months
- Median OS: 12.6 months
โ Regulatory Update
- In June 2024, the FDA granted accelerated approval for the combination of adagrasib + cetuximab in patients with previously treated KRAS G12C-mutant metastatic CRC.