CodeBreak 100: Phase 2 Trial of Sotorasib in KRASG12C Mutated Non–Small Cell Lung Cancer

Alexander Spira, MD, PhD, FACP, presents slides from the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer (WCLC) from CodeBreak 100, the phase 2 trial of sotorasib in KRASG12C-mutated non–small cell lung cancer.

Alexander Spira, MD, PhD, FACP, discusses data from the following presentation:

• CodeBreaK 100: Registrational Phase 2 Trial of Sotorasib in KRAS p.G12C Mutated Non–Small Cell Lung Cancer. (Li, WCLC 2020, Abstract PS02.07)
  • Sotorasib, the first in class KRASG12C inhibitor administered as once daily oral therapy, demonstrated early, deep, and durable responses in the advanced NSCLC cohort from the phase 2 CodeBreaK 100 trial.
    • ORR was 37.1%, with median DoR of 10.0 months and median PFS of 6.8 months, validating the phase 1 results.
  • Sotorasib was well tolerated with no deaths attributed to treatment and low incidence of grade 3 or 4 treatment-related adverse events, treatment discontinuation, and dose modification.
  • Tumor response to sotorasib was observed across a range of biomarker subgroups, including patients with negative or low PD-L1 expression level and those with mutated STK11.
  • Breakthrough therapy designation was granted by FDA; regulatory filings based on current data are underway.
  • Confirmatory phase 3 CodeBreaK 200 trial is enrolling (clincaltrials.gov identifier: NCT04303780).