KRYSTAL-1: REGISTRATIONAL STUDY OF SAFETY AND EFFICACY OF KRAZATI
The safety and efficacy of KRAZATI were evaluated in patients with KRAS G12C-mutated, locally advanced or metastatic NSCLC who received at least one prior systemic therapy in KRYSTAL-1, a multicenter, single-arm, open-label expansion cohort study. 116 patients were enrolled; 112 were evaluable.1
NSCLC=non-small cell lung cancer.
KRYSTAL-1 REGISTRATIONAL STUDY1
KEY INCLUSION CRITERIA
Locally advanced or metastatic NSCLC1
Confirmed KRAS G12C mutation determined in tumor tissue1
Previously treated with an I-O-based regimen1*
Stable brain metastases allowed2†
KRAZATI 600 mg BID
Until unacceptable toxicity or disease progression1
Key exclusion criteria included history of intestinal disease or major gastric surgery likely to alter absorption of medication or inability to swallow oral medications, active brain metastases, carcinomatous meningitis, other active cancer.2
*Platinum-based regimen and an immune checkpoint inhibitor.1
†Patients were eligible if brain metastases were adequately treated and patients were neurologically stable ≥2 weeks prior to enrollment without the use of corticosteroids or were on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent).2
BID=twice-daily; DOR=duration of response; I-O=immunotherapy; ORR=objective response rate.
BASELINE DEMOGRAPHICS1,2
There is no recommendation for a washout period after an I-O-based regimen in the KRAZATI Prescribing Information.
ECOG PS=Eastern Cooperative Oncology Group Performance Status.
References:
- KRAZATI®. Prescribing information. Princeton, NJ. Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024.
- Jänne PA, Riely GJ, Gadgeel SM, et al. Adagrasib in non-small-cell lung cancer harboring a KRASG12C mutation. N Engl J Med. 2022;387(2):120-131.
- Data on file. Cohort A Academic or Community. Princeton, NJ: Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024.