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KRYSTAL-1 and KRYSTAL-12 EFFICACY

REGISTRATIONAL PHASE 2 COHORT1

THE ACCELERATED APPROVAL FOR KRAZATI® WAS BASED ON A ROBUST RESPONSE TO A RELENTLESS DISEASE2

KRAZATI® (adagrasib) Overall Response Rate (ORR) and median Duration of Response (mDOR)
KRAZATI® (adagrasib) Overall Response Rate (ORR) and median Duration of Response (mDOR)

58% HAD A RESPONSE DURATION OF ≥6 MONTHS2

  • 42% of patients (n=112) achieved a PR, and 0.9% of patients achieved a CR3
  • Median time to response was 1.4 months (range: 0.9–7.2)3
  • At data cutoff, treatment was ongoing in 50% (24/48) of patients who experienced a response1,4

*Tumor response was assessed by BICR. Phase 2 data cutoff: October 15, 2021 (median follow-up: 12.9 months).3
BICR=blinded independent central review; CI=confidence interval; CR=complete response; mDOR=median duration of response; NSCLC=non-small cell lung cancer; ORR=objective response rate; PR=partial response.

References:

  1. Spira AI, Riely GJ, Gadgeel SM, et al. KRYSTAL-1: activity and safety of adagrasib (MRTX849) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) harboring KRASG12C mutation. Oral presentation at ASCO 2022. Abstract 9002.
  2. KRAZATI®. Prescribing information. Princeton, NJ. Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024.
  3. 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.
  4. Data on file, Mirati Therapeutics.

KRAZATI® DELIVERED SUPERIOR PFS AND ORR VS DOCETAXEL1

KRAZATI REDUCED THE RISK OF DISEASE PROGRESSION OR DEATH BY 42% VS DOCETAXEL

PFS WITH KRAZATI VS DOCETAXEL1

Progression-free survival (PFS) with KRAZATI® (adagrasib) vs docetaxel

ORR WITH KRAZATI VS DOCETAXEL

Overall Response Rate (ORR) with KRAZATI® (adagrasib) vs docetaxel

Median follow-up time was 7.2 months.1 Data cutoff: December 31, 2023.1

*Per BICR (RECIST v1.1).1
BICR=blinded independent central review; CI=confidence interval; HR=hazard ratio; PFS=progression-free survival; ORR=objective response rate; RECIST=Response Evaluation Criteria in Solid Tumors.

Reference:

  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.

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.

 

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