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REGN2810

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.

REGENERON PHARMACEUTICALS, INC. REGN · Non-small Cell Lung Cancer

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
REGENERON PHARMACEUTICALS, INC. REGN Source: Company record for REGENERON PHARMACEUTICALS, INC. (opens in a new tab)
Indication
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 6 Mar 20181 linked trial
  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 REGN2810. Editors add each one with its source.

Filed application

No filed application is on record for REGN2810. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for REGN2810.

Clinical trials

Trials linked to REGN2810
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT03409614ClinicalTrials.gov record for NCT03409614 (opens in a new tab)Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung CancerPhase 3Completed789 (actual)27 Feb 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03409614 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT03409614

  • Part 1: Overall Survival (OS) (months)
    • Part 1: Cemiplimab + Chemotherapy vs Part 1: Chemotherapy: Hazard Ratio (HR) 0.813 (95% CI 0.601 to 1.100), p-value 0.1782, Stratified Log Rank, superiority
    • Part 1: Cemiplimab+AbbrevChemo+Ipilimumab vs Part 1: Chemotherapy: Hazard Ratio (HR) 0.642 (95% CI 0.472 to 0.874), superiority
  • Part 2: OS (months)
    • Part 2: Cemiplimab + Chemotherapy vs Part 2: Placebo + Chemotherapy: Hazard Ratio (HR) 0.662 (95% CI 0.531 to 0.825), p-value 0.0002, Stratified Log Rank, superiority

Serious adverse events (From the time the informed consent was signed, up to approximately 83 months): Part 1: Cemiplimab + Chemotherapy 38 of 108; Part 1: Cemiplimab+AbbrevChemo+Ipilimumab 39 of 109; Part 1: Chemotherapy 23 of 103; Part 1: Chemotherapy to Cemiplimab 7 of 31; Part 2: Cemiplimab + Chemotherapy 95 of 312; Part 2: Placebo + Chemotherapy 38 of 153

Source: ClinicalTrials.gov results for NCT03409614 (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 NCT03409614 (4), newest first

  1. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 ≥ 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial.

    Lung cancer (Amsterdam, Netherlands) · 2024 Jul

    PubMed 38820979 (opens in a new tab)DOI 10.1016/j.lungcan.2024.107821 (opens in a new tab)

  2. Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023 Jul

    PubMed 37348996 (opens in a new tab)DOI 10.1016/j.jtho.2023.04.001 (opens in a new tab)

  3. Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023 Jun

    PubMed 37001859 (opens in a new tab)DOI 10.1016/j.jtho.2023.03.008 (opens in a new tab)

  4. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.

    Nature medicine · 2022 Nov

    PubMed 36008722 (opens in a new tab)DOI 10.1038/s41591-022-01977-y (opens in a new tab)

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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FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as REGN2810.

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.