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CodeBreaK 100

Sotorasib in KRAS p.G12C-mutated advanced pancreatic cancer (CodeBreaK 100, pancreatic cohort)

Phase 1/2N = 38NCT03600883

Population
KRAS p.G12C-mutated pancreatic cancer, metastatic, at least one prior systemic therapy
Design
Single-group phase 1-2 trial of sotorasib (960 mg orally once daily in phase 2) in previously treated KRAS p.G12C-mutated pancreatic cancer. Primary end point of phase 2: centrally confirmed objective response. Efficacy reported in the pooled phase 1 and phase 2 population. Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Sotorasib (experimental, n = 38): Sotorasib orally once daily
People
Strickler JH
Show the numbers
Results reported for CodeBreaK 100
EndpointAnalysisSotorasibControlEffect
ORRPooled phase 1 and 2 population (38)Centrally confirmed objective response (complete or partial)primaryStrickler 202321% (10–37%)—8 of 38 patients.
PFSPooled phase 1 and 2 population (38)primaryStrickler 2023median 4 months (2.8–5.6)——
OSPooled phase 1 and 2 population (38)primaryStrickler 2023median 6.9 months (5.0–9.1)——
Results reported for CodeBreaK 100
EndpointAnalysisSotorasibControlEffect
ORRPooled phase 1 and 2 population (38)Centrally confirmed objective response (complete or partial)primaryStrickler 202321% (10–37%)—8 of 38 patients.
PFSPooled phase 1 and 2 population (38)primaryStrickler 2023median 4 months (2.8–5.6)——
OSPooled phase 1 and 2 population (38)primaryStrickler 2023median 6.9 months (5.0–9.1)——
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0246810Months (modelled)
  • Sotorasib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSotorasib
0100.0%
359.5%
542.0%
825.0%
1017.7%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015Months (modelled)
  • Sotorasib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSotorasib
0100.0%
466.9%
940.5%
1327.1%
1718.1%
Primary publication: Strickler JH, Satake H, George TJ, Yaeger R, Hollebecque A, Garrido-Laguna I, et al. Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer. N Engl J Med. 2023;388(1):33-43. PubMedDOI

Appears in

Sources

  1. Strickler JH, Satake H, George TJ, Yaeger R, Hollebecque A, Garrido-Laguna I, et al. Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer. N Engl J Med. 2023;388(1):33-43.

    PubMedDOI