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KRYSTAL-1 and KRYSTAL-12 STUDY DESIGNS

KRYSTAL-1 STUDY DESIGN1

Registrational study of efficacy and safety

The safety and efficacy of KRAZATI® (adagrasib) were evaluated in patients with KRAS G12C–mutated, locally advanced, or metastatic NSCLC who received at least 1 prior systemic therapy in KRYSTAL-1, a multicenter, single-arm, open-label expansion cohort study. 116 patients were enrolled; 112 were evaluable.1

N=116

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†

Medicine bottle

KRAZATI 600 mg PO BID

Until unacceptable toxicity or disease progression1

Target
Primary endpoint ORR
Select secondary endpoints DOR and Safety
Files

Key exclusion criteria included history of intestinal disease or major gastric surgery likely to alter absorption of medication, 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; KRAS=Kirsten rat sarcoma viral oncogene homologue; NSCLC=non-small cell lung cancer; ORR=objective response rate.

BASELINE CHARACTERISTICS1,2

In KRYSTAL-1, 98% of patients previously received an I-O–⁠based regimen1

Key baseline demographics KRYSTAL-1 study, chart

ECOG PS=Eastern Cooperative Oncology Group performance status.

References:

  1. KRAZATI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  2. 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.
  3. Data on file. Cohort A Academic or Community. Princeton, NJ: Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024.

KRYSTAL-12 STUDY DESIGN1

Phase 3 study of efficacy and safety

N=453

KEY INCLUSION CRITERIA1

  • Locally advanced or metastatic NSCLC with KRAS G12C mutation

  • Prior treatment with platinum-based chemotherapy and
    anti–PD-(L)1 therapy

  • ECOG PS 0-1

  • Stable brain metastases allowed  

Medicine bottle icon
KRYSTAL-12 Study Design, chart
Target icon
Primary endpoint PFS
Select Secondary Endpoints ORR, DOR, and safety
Files icon

Key exclusion criteria included prior treatment with a
KRAS G12C inhibitor and/or active brain metastases.2

 *  Crossover from docetaxel to KRAZATI was allowed in cases where disease progression per RECIST v1.1 was confirmed by real-time BICR. Other crossover criteria: ECOG PS 0-2, recovery from DOCE-related AEs to grade 1 or baseline (except peripheral neuropathy and alopecia for which grade 2 is acceptable).1
  †  Per BICR (RECIST v1.1).2
  AE=adverse event; BICR=blinded independent central review; BID=twice daily; DOCE=docetaxel; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; IV=intravenous; KRAS=Kirsten rat sarcoma viral oncogene homologue; NSCLC=non-small cell lung cancer; ORR=objective response rate; L1=programmed death-ligand 1; PFS=progression-free survival; PO=orally; Q3W=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors.

BASELINE CHARACTERISTICS1

In KRYSTAL-12, 100% of patients previously received an I-O–based regimen1

Key baseline demographics KRYSTAL-12 study, chart

*Data missing for one patient in the docetaxel group.1
I-O=immunotherapy

References:

  1. Mok TSK, Yao W, Duruisseaux M, et al. KRYSTAL-12: phase 3 study of adagrasib versus docetaxel in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Oral presentation at ASCO 2024. Abstract LBA8509.
  2. Clinicaltrials.gov. NCT04685135. Accessed November 11, 2025.
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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Gastrointestinal Adverse Reactions

 

  • KRAZATI can cause severe gastrointestinal adverse reactions

  • Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity

QTc Interval Prolongation

 

  • KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (eg, torsades de pointes) or sudden death

  • Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation

  • Monitor ECGs and electrolytes, particularly potassium and magnesium, prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are unable to avoid concomitant medications that are known to prolong the QT interval. Correct electrolyte abnormalities. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity

Hepatotoxicity

 

  • KRAZATI can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis

  • Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity

Interstitial Lung Disease/Pneumonitis

 

  • KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal

  • Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with KRAZATI. Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified

ADVERSE REACTIONS

 

  • Serious adverse reactions occurred in 57% of 116 patients who received adagrasib in NSCLC patients. The most common adverse reactions in NSCLC patients (≥20%) were diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation

DRUG INTERACTIONS

 

  • Strong CYP3A4 Inducers: Avoid concomitant use.

  • Strong CYP3A4 Inhibitors: Avoid concomitant use until adagrasib concentrations have reached steady state (after ~8 days).

  • Sensitive CYP3A4 Substrates: Avoid concomitant use with sensitive CYP3A4 substrates.

  • Sensitive CYP2C9 or CYP2D6 Substrates or P-gp Substrates: Avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions.

  • Drugs That Prolong QT Interval: Avoid concomitant use with KRAZATI.

Please see Drug Interactions Section of the Full Prescribing Information for additional information.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential

 
  • Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential

Lactation

 
  • Advise not to breastfeed

Please see Full Prescribing Information.

 

1914-US-2500139   01/26

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1914-US-2500138   01/26

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