Adagrasib, also called “Krazati”, is a tablet taken by mouth which inhibits KRAS G12C mutation. It has shown clinical activity in pretreated patients with several tumor types, including colorectal cancer.
On 12 December 2022, the US Food and Drug Administration (FDA) granted accelerated approval to Krazati for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation.
Methods of the Study
In this phase 1–2 clinical trial, heavily pretreated patients were assigned with metastatic colorectal cancer with mutant KRAS G12C to receive Krazati monotherapy (600 mg orally twice daily) or Krazati (at the same dose) in combination with intravenous Cetuximab once a week or every 2 weeks.
In the monotherapy group a response was reported in 19% of the patients.
The median response duration was 4.3 months.
The median Progression-Free Survival, which is the length of time until disease progression, was 5.6 months.
In the combination-therapy group, 46% of the patients responded to the treatment.
The median response duration was 7.6 months.
The median Progression-Free Survival was 6.9 months.
The percentage of harsh treatment-related side effects was 34% in the monotherapy group and 16% in the combination-therapy group.
No deaths were observed.
The median response duration was more than 6 months in the combination-therapy group.
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