MRTX849

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Mirati Therapeutics, Inc. · Advanced Colorectal Cancer; Advanced Non Small Cell Lung Cancer; Metastatic Colorectal Cancer; Metastatic Non Small Cell Lung Cancer

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indications
Advanced Colorectal Cancer; Advanced Non Small Cell Lung Cancer; Metastatic Colorectal Cancer; Metastatic Non Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 23 Feb 20212 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for MRTX849. Editors add each one with its source.

Filed application

No filed application is on record for MRTX849. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for MRTX849.

Clinical trials

Trials linked to MRTX849
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT04793958ClinicalTrials.gov record for NCT04793958 (opens in a new tab)Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)Phase 3Active, not recruiting461 (actual)16 Jan 2026 (actual) No

Publications listing NCT04793958 (1), newest first

  1. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer.

    Journal of the National Comprehensive Cancer Network : JNCCN · 2025 Jan 3

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT04685135ClinicalTrials.gov record for NCT04685135 (opens in a new tab)KRYSTAL-12Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C MutationPhase 3Active, not recruiting453 (actual)30 Dec 2023 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04685135 (opens in a new tab)

Posted results on ClinicalTrials.gov for KRYSTAL-12

  • Progression-Free Survival (PFS) as Per Blinded Independent Central Review (months)
    • Adagrasib vs Docetaxel: Hazard Ratio (HR) 0.58 (95% CI 0.45 to 0.76), p-value <0.0001, Log Rank, superiority

Serious adverse events (All cause mortality and non serious adverse events were reported from first first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks). Serious adverse events were collected from date of signing of informed consent form till 28 days after last dose (Up to approximately 111 weeks).): Adagrasib 149 of 298; Docetaxel 50 of 140; Crossover Adagrasib 20 of 44

Source: ClinicalTrials.gov results for NCT04685135 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing KRYSTAL-12 (2), newest first

  1. Plain language summary of the KRYSTAL-12 study results: adagrasib for non-small cell lung cancer with KRAS(G12C) mutations.

    Future oncology (London, England) · 2026 Aug

  2. Adagrasib versus docetaxel in KRAS(G12C)-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial.

    Lancet (London, England) · 2025 Aug 9

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

No FDA approvals on record for this drug.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as MRTX849.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.