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Association details:
| Biomarker: | KRAS G12C |
|---|---|
| Cancer: | Non Small Cell Lung 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:
OA03.04 - Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation
Published date:
07/12/2022
Excerpt:
The unconfirmed overall response rate (ORR) in pts with NSCLC was 43% (15/37 pts), while the confirmed ORR was 37% (13/37 pts) across dose levels. Approximately 90% or higher target engagement was achieved at multiple dose levels in pts with NSCLC. GDC-6036 exhibits encouraging clinical activity and high target engagement levels across dose levels in NSCLC with a KRAS G12C mutation. This study has also demonstrated a wide therapeutic range for GDC-6036 (50- 400 mg), an acceptable safety profile with manageable and reversible AEs, and a PK profile compatible with once-daily dosing.
Trial ID:
