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fianlimab+cemiplimab

Phase 2

Head and Neck Squamous Cell Carcinoma (HNSCC) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 6, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06769698A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaPHASE2 RECRUITING 120 — — Apr 14, 2026Dec 28, 2030May 6, 202610 United States, Australia
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR)
Up to 90 days after last study treatment, approximately 58 months
Secondary Endpoints
Incidence of Adverse Events (AEs)
Up to 90 days after last study treatment, approximately 58 months
Severity of AEs
Up to 90 days after last study treatment, approximately 58 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
Up to 90 days after last study treatment, approximately 58 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALApproximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo.
Cohort 2EXPERIMENTALApproximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1.
Interventions
NameTypeDescription
FDC fianlimab+cemiplimabDRUGFixed-Dose Combination (FDC) Administered per the protocol
CemiplimabDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria: 1. Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies 2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol...

Countries:United StatesAustralia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06769698Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT06769698studyFirstPostDate: changed