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Association details:
| Biomarker: | KRAS G12C |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | divarasib (RG6330) (KRAS G12C inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Excerpt:
...- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation....
Trial ID:
Source:
Title:
Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation
Published date:
08/24/2023
Excerpt:
Among patients with NSCLC, a confirmed response was observed in 53.4% of patients (95% confidence interval [CI], 39.9 to 66.7), and the median progression-free survival was 13.1 months....Among patients with colorectal cancer, a confirmed response was observed in 29.1% of patients (95% CI, 17.6 to 42.9), and the median progression-free survival was 5.6 months (95% CI, 4.1 to 8.2). Responses were also observed in patients with other solid tumors....Treatment with divarasib resulted in durable clinical responses across KRAS G12C–positive tumors, with mostly low-grade adverse events.
DOI:
10.1056/NEJMoa2303810
Trial ID:
Source:
Title:
362P - Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutation
Published date:
09/05/2022
Excerpt:
Across all solid tumor patients, the mean half-life for GDC-6036 ranged from 13-17 hours at doses of 50-400 mg. The unconfirmed overall response rate (ORR) in pts with CRC was 29% (12/41 pts with measurable disease; 1 complete response), while the confirmed ORR was 20% (8/41 pts) across dose levels in this ongoing study....In patients with KRAS G12C mutant CRC, GDC-6036 demonstrated encouraging antitumor activity and early reduction in ctDNA along with acceptable and manageable safety, and PK profile compatible with once daily dosing.
