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REGN2810

Phase 3

Non-small Cell Lung Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment789
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03409614Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung CancerPHASE3 COMPLETED 789Mar 6, 2018Feb 27, 2025May 18, 2026133 United States, Austria +16
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Study Endpoints
Primary Endpoints
Part 1: Overall Survival (OS)
Up to a maximum of 82.2 months

OS was defined as the time from randomization to the date of death due to any cause.

Part 2: OS
Up to a maximum of 68.4 months

OS was defined as the time from randomization to the date of death due to any cause.

Secondary Endpoints
Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)
Up to a maximum of 82.2 months
Part 2: PFS Per IRC
Up to a maximum of 68.4 months
Part 1: Objective Response Rate (ORR) Per IRC
Up to 32 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ChemoOTHERPart 1: Chemotherapy
REGN2810+Chemo Part 1EXPERIMENTALPart 1: REGN2810+chemo
REGN2810+AbbrevChemo+ipiEXPERIMENTALPart 1: REGN2810+abbrev chemo+ipi
Placebo+ChemoEXPERIMENTALPart 2: Placebo plus chemo
REGN2810+Chemo Part 2EXPERIMENTALPart 2: REGN2810+chemo
Interventions
NameTypeDescription
REGN2810DRUGREGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810/chemo/ipiDRUGREGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
ChemotherapyOTHERPlatinum-based doublet chemotherapy Part 1
PlaceboDRUGMatching placebo Part 2
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites133

Key Inclusion Criteria: 1. Men and women ≥20 years of age for Japanese patients 2. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with ...

Countries:United StatesAustriaChinaFranceGeorgiaGreeceIrelandItalyLithuaniaMalaysiaPolandRomaniaRussiaSlovakiaSouth KoreaThailandTurkey (Türkiye)Ukraine
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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