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BNT116

Phase 2

Advanced Non-Small Cell Lung Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 6, 2026

Target and mechanism

Molecular targetLAG-3
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

BNT116 · 1 trial · 1 indication

Phase 2 1
NCT05557591A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)Advanced Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING51 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)
Advanced Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Up to 136 weeks from randomization

Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

Secondary Endpoints

ORR by investigator assessment
Up to 136 weeks from randomization
Duration of Response (DOR) as assessed by BIRC using RECIST 1.1
Up to 3 years from last patient randomized
DOR by investigator assessment
Up to 3 years from last patient randomized
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 2: CemiplimabEXPERIMENTALArm A: Cemiplimab is administered by IV infusion Q3W
Phase 2: BNT116 + CemiplimabEXPERIMENTALArm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Interventions

NameTypeDescription
BNT116DRUGBNT116 is administered by IV injection.
CemiplimabDRUGCemiplimab is administered Q3W by IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites52

Key Inclusion Criteria 1. Participants with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic) disease who received no prior systemic treatment...

Countries:United StatesGeorgiaGermanySouth KoreaSpainTaiwanTurkey (Türkiye)
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Advanced Non-Small Cell Lung Cancer")

Frequently asked questions about BNT116

What is BNT116 used for in Advanced Non-Small Cell Lung Cancer?

BNT116 is an investigational cancer vaccine being studied for the treatment of advanced non-small cell lung cancer. It is currently in Phase 2 clinical development and is being evaluated in combination with cemiplimab in adults with this condition.

What does BNT116 target?

BNT116 targets LAG-3, a protein involved in immune regulation. By targeting LAG-3, the vaccine aims to stimulate an immune response against cancer cells. It is being studied as a potential treatment for advanced non-small cell lung cancer.

Who makes BNT116?

BNT116 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in advanced non-small cell lung cancer.

What phase is BNT116 in?

BNT116 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of advanced non-small cell lung cancer.

What clinical trials is BNT116 in?

BNT116 is being studied in a Phase 2 clinical trial with the identifier NCT05557591. This trial, known as EMPOWERVAX Lung 1, is evaluating the combination of BNT116 with cemiplimab in adults with advanced non-small cell lung cancer. The trial is active but not recruiting participants.

Is BNT116 the same as a cancer vaccine?

Yes, BNT116 is a cancer vaccine designed to treat advanced non-small cell lung cancer. It is being studied in combination with cemiplimab in a Phase 2 clinical trial. The vaccine targets LAG-3, a protein involved in immune response regulation.