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Sotorasib Monotherapy for Patients With KRAS G12C-Mutated Pancreatic Cancer
Results from the Phase 1/2 CodeBreaK 100 Trial
Results from the Phase 1/2 CodeBreaK 100 Trial
In a phase 1/2 trial, sotorasib demonstrated acceptable safety and anticancer activity for patients with advanced pancreatic cancer and KRAS mutation who had received prior treatment.
In the CodeBreaK 100 trial, 38 patients with KRAS p.G12C-mutated pancreatic cancer who had previously received ≥1 systemic therapy were enrolled. All patients had metastatic disease and had been treated with prior chemotherapy. In phase 1, the recommended dose for phase 2 was determined.
In phase 2, patients received 960 mg of oral sotorasib daily. The primary end point for phase 2 was objective response. End points assessed in both phases included objective response, progression-free survival, overall survival, and safety.
A total of 8 patients achieved an objective response (21%; 95% confidence interval [CI], 10 to 37). The median progression-free survival was 4.0 months (95% CI, 2.8 to 5.6) and median overall survival was 6.9 months (95% CI, 5.0 to 9.1).
There were treatment-related adverse events in 42% of all patients, with 16% experiencing a grade 3 event. No events led to either treatment discontinuation or death.
Study authors concluded, “Sotorasib showed anticancer activity and had an acceptable safety profile in patients with KRAS p.G12C-mutated advanced pancreatic cancer who had received previously treatment.”
Source:
Strickler JH, Satake H, George TJ, et al. Sotorasib in KRAS p.G12C-mutated advanced pancreatic cancer. New Eng J Med. Published online: January 5, 2023. doi:10.1056/NEJMoa220847
