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CodeBreaK 100

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Phase 1/2N = 126NCT03600883

Population
KRAS p.G12C-mutated advanced NSCLC previously treated with standard therapies (81.0% had received both platinum-based chemotherapy and PD-1 or PD-L1 inhibitors)
Design
Single-group phase 2 part reported for NSCLC: sotorasib 960 mg orally once daily in previously treated KRAS p.G12C-mutated advanced NSCLC. Primary endpoint objective response by independent central review. Median follow-up 15.3 months at the 15 March 2021 data cutoff (full text).
Primary endpoint
ORR
Arms
  • Sotorasib (experimental, n = 126): Sotorasib 960 mg orally once daily
People
Skoulidis F
Show the numbers
Results reported for CodeBreaK 100
EndpointAnalysisSotorasibControlEffect
ORRPatients with measurable disease at baseline evaluated for response by central review (n=124)Complete or partial response according to independent central reviewprimarySkoulidis 202137.1% (28.6–46.2%)—46 of 124 patients responded (4 complete, 42 partial responses). Disease control 80.6% (95% CI 72.6 to 87.2). Single-arm: no control group.
DORResponders by central review (n=46)primarySkoulidis 2021median 11.1 months—95% CI 6.9 to could not be evaluated (upper bound not reported).
PFSPatients evaluable for response (n=124)primarySkoulidis 2021median 6.8 months (5.1–8.2)——
OSAll enrolled patients (n=126)primarySkoulidis 2021median 12.5 months—95% CI 10.0 to could not be evaluated (upper bound not reported).
Results reported for CodeBreaK 100
EndpointAnalysisSotorasibControlEffect
ORRPatients with measurable disease at baseline evaluated for response by central review (n=124)Complete or partial response according to independent central reviewprimarySkoulidis 202137.1% (28.6–46.2%)—46 of 124 patients responded (4 complete, 42 partial responses). Disease control 80.6% (95% CI 72.6 to 87.2). Single-arm: no control group.
DORResponders by central review (n=46)primarySkoulidis 2021median 11.1 months—95% CI 6.9 to could not be evaluated (upper bound not reported).
PFSPatients evaluable for response (n=124)primarySkoulidis 2021median 6.8 months (5.1–8.2)——
OSAll enrolled patients (n=126)primarySkoulidis 2021median 12.5 months—95% CI 10.0 to could not be evaluated (upper bound not reported).
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0510152025Months (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%
764.6%
1441.7%
2126.9%
2817.4%
Illustrative — modelled from reported values, not trial data. PFS, 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%
466.5%
940.0%
1326.6%
1717.7%
Primary publication: Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, et al. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021;384(25):2371-2381. PubMedDOI

Appears in

Sources

  1. Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, et al. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021;384(25):2371-2381.

    PubMedDOI