TAS-102

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.

Merck & Co., Inc. MRK · Colorectal Cancer; Colorectal Neoplasms

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    3

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indications
Colorectal Cancer; Colorectal Neoplasms 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 29 Mar 20213 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 TAS-102. Editors add each one with its source.

Filed application

No filed application is on record for TAS-102. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for TAS-102.

Clinical trials

Trials linked to TAS-102
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT05600309ClinicalTrials.gov record for NCT05600309 (opens in a new tab)A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension StudyPhase 3Completed94 (actual)15 Aug 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT05600309 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT05600309

  • Overall Survival (OS) (Months)
    • Favezelimab/Pembrolizumab vs Standard of Care (Regorafenib or TAS-102): Hazard Ratio (HR) 0.94 (95% CI 0.59 to 1.50), p-value 0.3914, Log Rank, other

Serious adverse events (Up to approximately 30 months): Favezelimab/Pembrolizumab 12 of 49; Standard of Care (Regorafenib or TAS-102) 13 of 44

Source: ClinicalTrials.gov results for NCT05600309 (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.

NCT05064059ClinicalTrials.gov record for NCT05064059 (opens in a new tab)A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)Phase 3Completed441 (actual)15 Aug 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT05064059 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT05064059

  • Overall Survival (OS) (Months)
    • Favezelimab/Pembrolizumab vs Standard of Care (Regorafenib or TAS-102): Hazard Ratio (HR) 0.98 (95% CI 0.80 to 1.20), p-value 0.4183, Log Rank, superiority

Serious adverse events (Up to approximately 38 months): Favezelimab/Pembrolizumab 75 of 221; Standard of Care (Regorafenib or TAS-102) 56 of 210

Source: ClinicalTrials.gov results for NCT05064059 (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 NCT05064059 (1), newest first

  1. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy.

    Journal of immunology research · 2026

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.

NCT04776148ClinicalTrials.gov record for NCT04776148 (opens in a new tab)Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)Phase 3Completed563 (actual)27 Sep 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04776148 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT04776148

  • Global Cohort: Overall Survival (OS) (Months)
    • Lenvatinib+Pembrolizumab vs Standard of Care (SOC) Treatment: Hazard Ratio (HR) 0.83 (95% CI 0.68 to 1.02), p-value 0.0379, Log Rank, superiority
  • China Cohort: Overall Survival (OS) (Months)
    • Lenvatinib+Pembrolizumab vs Standard of Care (SOC) Treatment: Hazard Ratio (HR) 0.92 (95% CI 0.60 to 1.42), p-value 0.3574, Log Rank, superiority

Serious adverse events (Up to approximately 41 months (through End of Trial database cut-off date of 27-Sep-2024)): Lenvatinib + Pembrolizumab 117 of 279; Standard Of Care Treatment 66 of 277

Source: ClinicalTrials.gov results for NCT04776148 (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 NCT04776148 (1), newest first

  1. Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 Aug 20

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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Orange Book patents load here.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as TAS-102.

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.