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KRYSTAL-1

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

Phase 1/2N = 116NCT03785249

Population
KRAS G12C-mutated NSCLC previously treated with platinum-based chemotherapy and anti-PD-1 or PD-L1 therapy (98.3% had received both)
Design
Registrational single-group phase 2 cohort of adagrasib 600 mg orally twice daily in KRAS G12C-mutated NSCLC previously treated with platinum-based chemotherapy and anti-PD-1 or PD-L1 therapy. Primary endpoint objective response by blinded independent central review.
Primary endpoint
ORR
Arms
  • Adagrasib (experimental, n = 116): Adagrasib 600 mg orally twice daily
People
Jänne PA
Show the numbers
Results reported for KRYSTAL-1
EndpointAnalysisAdagrasibControlEffect
ORRPatients with measurable disease at baseline (n=112)Confirmed objective response by blinded independent central reviewprimarymedian follow-up 12.9 monthsJänne 202242.9%—48 of 112 patients had a confirmed objective response; no confidence interval is given in the abstract.
DORRespondersprimarymedian follow-up 12.9 monthsJänne 2022median 8.5 months (6.2–13.8)——
PFSAnalysis population not stated in the abstract (116 patients treated)primarymedian follow-up 12.9 monthsJänne 2022median 6.5 months (4.7–8.4)——
OSAnalysis population not stated in the abstract (116 patients treated)primarymedian follow-up 15.6 monthsJänne 2022median 12.6 months (9.2–19.2)——
ORRPatients with previously treated, stable CNS metastases (n=33)Intracranial confirmed objective response rateexploratoryJänne 202233.3% (18.0–51.8%)—Reported in the abstract without an analysis label; 'exploratory' is used as the closest label in the schema's analysis vocabulary (which has no 'secondary'). 33 patients with previously treated, stable CNS metastases.
Results reported for KRYSTAL-1
EndpointAnalysisAdagrasibControlEffect
ORRPatients with measurable disease at baseline (n=112)Confirmed objective response by blinded independent central reviewprimarymedian follow-up 12.9 monthsJänne 202242.9%—48 of 112 patients had a confirmed objective response; no confidence interval is given in the abstract.
DORRespondersprimarymedian follow-up 12.9 monthsJänne 2022median 8.5 months (6.2–13.8)——
PFSAnalysis population not stated in the abstract (116 patients treated)primarymedian follow-up 12.9 monthsJänne 2022median 6.5 months (4.7–8.4)——
OSAnalysis population not stated in the abstract (116 patients treated)primarymedian follow-up 15.6 monthsJänne 2022median 12.6 months (9.2–19.2)——
ORRPatients with previously treated, stable CNS metastases (n=33)Intracranial confirmed objective response rateexploratoryJänne 202233.3% (18.0–51.8%)—Reported in the abstract without an analysis label; 'exploratory' is used as the closest label in the schema's analysis vocabulary (which has no 'secondary'). 33 patients with previously treated, stable CNS metastases.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%05101520Months (modelled)
  • Adagrasib (experimental)

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

Data table (modelled values)
MonthsAdagrasib
0100.0%
566.5%
1140.8%
1627.1%
2118.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Adagrasib (experimental)

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

Data table (modelled values)
MonthsAdagrasib
0100.0%
465.3%
842.6%
1227.8%
1618.2%
Primary publication: Jänne PA, Riely GJ, Gadgeel SM, Heist RS, Ou SI, Pacheco JM, et al. Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRAS(G12C) Mutation. N Engl J Med. 2022;387(2):120-131. PubMedDOI

Appears in

Sources

  1. Jänne PA, Riely GJ, Gadgeel SM, Heist RS, Ou SI, Pacheco JM, et al. Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRAS(G12C) Mutation. N Engl J Med. 2022;387(2):120-131.

    PubMedDOI